Sure / Dental Innovations
PANAVIA 21
Technique Sheet

Instructions for Use

 

KURARAY CO., LTD.

 

 

PANAVIA 21 – Kit Components

 

  1. PANAVIA 21 paste

Catalyst paste                                       4ml

Universal paste (EX, TC or OP)                  4ml

  1. ED PRIMER

Liquid A                                                         4ml

Liquid B                                                         4ml

  1. OXYGUARD II                                             6 ml
  2. PANAVIA ETCHING AGENT V                  5ml
  3. Mixing Pads (50 sheets)
  4. Spatula
  5. Mixing Dish
  6. Small Sponge Pledgets
  7. Disposable Brush Tips (50X2)
  8. Brush Tip Handles (2)

 

 

I. CLINICAL FEATURES

 

PANAVIA 21 is an advanced adhesive resin cement with improved dispensing, handling and bond strength properties.

 

PANAVIA 21 paste consists of Universal and Catalyst pastes, each being a low viscosity composite resin.  It contains the adhesive monomer MDP (10-Methacryloyloxydecyl dihydrogen phosphate) which provides long-term bond strength between tooth structure and metal, silanated porcelain or composite.

The newly developed adhesion primer, ED PRIMER, contains HEMA and 5-NMSA as well as MDP and consists of Liquid A and Liquid B.  ED PRIMER, when applied to enamel and dentin, promotes a strong bond between PANAVIA 21 paste and tooth structure.  Acid etching of dentin and cut enamel is not required with ED PRIMER; only uncut enamel is etched.

 

OXYGUARD II is a viscous gel used to block the oxygen from anaerobic setting PANAVIA 21 paste.  Applied to the restoration’s margin, it also contains a polymerization accelerator to provide more effective setting.

 

The highly viscous PANAVIA ETCHING AGENT V is an approximately 40% phosphoric acid gel (50% aqueous phosphoric acid + thickener) that is used to etch uncut enamel and to activate roughened porcelain prior to ED PRIMER or PANAVIA 21 application.

 

II. PHYSICAL PROPERTIES

 

A. Shear bond strength;

            Enamel

            Etched Enamel

            Dentin

            Ni-Cr alloy *1

            Gold alloy *2

            Porcelain *3

            Cured composite *3

            Fresh amalgam

 

            24hr: Stored in water at 37deg C for 24 hours

            TC 3000: Thermal cycled between 4deg C and 60deg C for one minute each

           

            *1 Sandblasted

            *2 Sandblasted and tin-plated

            *3 Silanated with CLEARFIL PORCELAIN BOND

 

B. Compressive strength; 290 Mpa

C. Flexural strength; 77 Mpa

D. Film thickness; 19 microns

E. Solubility; 1.4ug/mm3

F. Water absorption; 20ug/mm3

G. Working and setting time;

            Mixing (at 25deg C)                             20-30 sec

            Working time (at 25deg C)                      4 min

            Setting time from time of

            seating (at 35deg C)                             1 min

            Complete setting (at 35deg C)            3 min

 

III. INDICATIONS

 

PANAVIA 21 is available in three radiopaque shades: EX is partially translucent and white in color, TC is very translucent and tooth colored and OP is very opaque and dentin colored.

 

PANAVIA 21 is indicated in the following clinical situations:

 

 

EX, TC, OP INDICATION MATRIX

                                                                              EX                   TC                   OP

                                                                        (standard       (tooth              (opaque)

                                                                              white)     color)

Anterior adhesion bridge and splint                      ADQ                NOT REC     REC

Posterior adhesion bridge and splint                      REC                 REC                 REC

Metal inlay, onlay, crown and bridge                    REC                 REC                 ADQ

Silanated porcelain or cured

composite inlay, onlay and crown               NOT REC     REC                 NOT REC

Preformed post/Cast post and core                       REC                 REC                 REC

Amalgam bonding                                                REC                 ADQ                REC

 

REC; RECOMMENDED     ADQ; ADEQUATE     NOT REC; NOT RECOMMENDED

 

IV.  CLINICAL PROCEDURES

 

A. Cementation of Adhesion Bridges or Splints

     

            Treatment of Tooth Structure

  1. Prepare the abutment teeth allowing for proper retention grooves and occlusal rests. (Fig. A1)
  2. All uncut enamel areas should be etched twice with PANAVIA ETCHING AGENT V. (Fig. A-2) Buccal surfaces should be etched for 30 seconds, washed and dried, then re-etched for 30 seconds.  Lingual surfaces should be etched for 30 seconds, washed and dried, then re-etched for 60 seconds.

NOTE:  It is not necessary to acid-etch cut enamel or dentin surfaces when                cementing with PANAVIA 21.

  1. Dispense one drop of each ED PRIMER Liquid A and Liquid B into a well of the mixing dish and mix for three-five seconds. (Fig. A-3) Using a small sponge pledget apply the mixture to the prepared tooth surface. (Fig. A-4) After 60 seconds evaporate the volatiles with a gentle stream of air; the surface will appear glossy.

NOTE:  Do not apply ED PRIMER to the metal or silanated porcelain.  Do not rinse.

 

           

            Treatment of Metal

  1. Non-precious metals should be sandblasted with 30-50 micron alumina particles at an air pressure of 4.2-7 kg/cm2 (60-100 PSI); two to three seconds per cm2 will remove the luster producing a matte finish. (Fig. A-5)
  2. Precious and semi-precious metals should be sandblasted as above and them tin-plated. (Fig. A-6) A layer of tin approximately 0.5 microns thick should be deposited.  To avoid contamination do not touch the tin-plated surfaces.
  3. After sandblasting and after tin-plating, wash the casting in a stream of water for one minute then ultrasonically clean for two-three minutes in a neutral detergent solution. (Fig. A-7)

NOTE:  The prepared tooth surface and casting must be kept dry and contamination free.

 

 

Usage of PANAVIA 21 paste

  1. Remove the syringe cap and slowly rotate the dispensing knob ONE FULL TURN clockwise until it clicks. (Fig. A-8) This dispenses the proper ratio and amount of PANAVIA 21 Catalyst and Universal for the cementation of an adhesion bridge with two abutments.  If more PANAVIA 21 paste is required, dispense an additional FULL TURN.

NOTE:  PANAVIA 21 paste must always be dispensed in increments of full turns.

  1. Mix the dispensed Catalyst and Universal pastes for 20-30 seconds, creating a smooth, uniform paste. (Fig. A-9) Because of PANAVIA 21’s anaerobic properties the mix should be spread in a thin layer on the pad until ready to use.

 

 

Setting the Adhesion Bridge or Splint

  1. Apply a thin, even layer of PANAVIA 21 paste to the prepared, cleaned and dried metal surface, being careful to avoid air entrapment. (Fig. A-10)

NOTE:  DO NOT additionally apply PANAVIA 21 paste to the tooth surface primed with ED PRIMER as this will accelerate the set of PANAVIA 21 paste.

  1. Seat the restoration and apply finger pressure. (Fig. A-11) After about 60 seconds release pressure and remove the excess PANAVIA 21 at the margins with a small disposable brush tip starting first with the proximal surfaces. (Fig. A-12)
  2. With a disposable brush tip apply OXYGUARD II to the margin. (Fig. A-13) After three minutes remove the OXYGUARD II with a cotton roll and water spray.
  3. Any slight excess of PANAVIA 21 remaining at the margin can be removed with an explorer or small scaler.  The restoration can then be finished and polished with pumice and water. (Fig. A-14)

 

 

B. Cementation of Metal Crowns, Bridges or Inlays/Onlays

 

      Treatment of Tooth Structure

  1. The crown or cavity preparation should be in the normal manner. (Fig. B-1) Direct pulp exposures should be covered with calcium hydroxide.
  2. Dispense one drop of each ED PRIMER Liquid A and Liquid B into a well of the mixing dish and mix for three-five seconds.  Using a small sponge pledget apply the mixture to both the dentin and enamel simultaneously. (Fig. B-2) After 60 seconds evaporate the volatiles with a gentle stream of air; the surface will appear glossy.

NOTE:  Do not apply ED PRIMER to the metal.  Do not rinse.

 

 

Treatment of Metal

  1. Non-precious metals should be sandblasted with 30-50 micron alumina particles at an air pressure of 4.2-7 kg/cm2 (60-100 PSI); two to three seconds per cm2 will remove the luster producing a matte finish. (Fig. B-3)
  2. Precious and semi-precious metals should be sandblasted as above and then tin-plated. (Fig. B-4) A layer of tin approximately 0.5 microns thick should be deposited.  To avoid contamination do not touch the tin-plated surface.
  3. After sandblasting and after tin-plating, wash the casting in a stream of water for one minute then ultrasonically clean for two-three minutes in a neutral detergent solution.

NOTE:  The prepared tooth surface and casting must be kept dry and contamination free.

 

 

Usage of PANAVIA paste

  1. Remove the syringe cap and slowly rotate the dispensing knob ONE FULL TURN clockwise until it clicks.  This dispenses the proper ratio and amount of PANAVIA 21 Catalyst and Universal for the cementation of one full crown.  If more PANAVIA 21 paste is required, dispense an additional FULL TURN.

NOTE:  PANAVIA 21 paste must always be dispensed in increments of full turns.

  1. Mix the dispensed Catalyst and Universal pastes for 20-30 seconds, creating a smooth, uniform paste.   Because of PANAVIA 21’s anaerobic properties the mix should be spread in a thin layer on the pad until ready to use.

 

 

Seating the Crown, Bridge or Inlay/Onlay

  1. Apply a thin, even layer of PANAVIA 21 paste to the prepared, cleaned and dried metal surface, being careful to avoid air entrapment. (Fig B-5)

NOTE:  DO NOT additionally apply PANAVIA 21 paste to the tooth surface primed with ED PRIMER as this will accelerate the set of PANAVIA 21 paste.

  1. Seat the restoration and apply finger pressure. (Fig. B-6) After about 60 seconds release pressure and remove the excess PANAVIA 21 at the margins with a disposable brush tip starting first with the proximal surfaces. (Fig. B-7)
  2. With a disposable brush tip apply OXYGUARD II to the margin. (Fig. B-8) After three minutes remove the OXYGUARD II with a cotton roll and water spray.
  3. Any slight excess of PANAVIA 21 remaining at the margin can be removed with an explorer or small scaler.  The restoration can then be finished and polished with pumice and water. (Fig. B-9)

 

 

 

C. Cementation of Silanated Porcelain and Cured Composite Crowns or Inlays/Onlays

Marginal adaptation is an important factor on occlusal surfaces. Since cement wear is higher than restoration wear, it is recommended that a marginal gap of over 50 microns not be accepted for occlusal surface restorations.

 

            Treatment of Tooth Structure

  1. The crown or cavity preparation should be in the normal manner. (Fig. C-1) Direct pulp exposures should be covered with calcium hydroxide.
  2. Dispense one drop of each ED PRIMER Liquid A and Liquid B into a well of the mixing dish and mix for three-five seconds.  Using a small sponge pledget apply the mixture to both the dentin and enamel simultaneously. (Fig. C-2) After 60 seconds evaporate the volatiles with a gentle stream of air; the surface will appear glossy.

NOTE: Do not apply ED PRIMER to the silanated porcelain or cured composite.  Do not rinse.

 

 

Treatment of Porcelain

  1. To maximize surface area, sandblast the internal surface with 30-50 micron alumina particles at an air pressure of 4.2-7 kg/cm2 (60-100 PSI) for two-three seconds per cm2. (Fig. C-3) Clean ultrasonically in water for two minutes.
  2. Activate the roughened porcelain surface by applying PANAVIA ETCHING AGENT V for five seconds; wash and dry. (Fig. C-4)
  3. Silanate the internal surface of the restoration with CLEARFIL PORCELAIN BOND ACTIVATOR mixed with either CLEARFIL NEW BOND or CLEARFIL PHOTO BOND per their Instructions for Use. (Fig. C-5)

 

 

Treatment of Cured composite

  1. Activate the internal surface of the cured composite by applying PANAVIA ETCHING AGENT V for five seconds; wash and dry. (Fig. C-6)
  2. Silanate the internal surface of the restoration with CLEARFIL PORCELAIN BOND ACTIVATOR mixed with either CLEARFIL NEW BOND or CLEARFIL PHOTO BOND per their Instructions for Use.

 

 

Usage of PANAVIA 21 paste

  1. Remove the syringe cap and slowly rotate the dispensing knob ONE FULL TURN clockwise until it clicks. This dispenses the proper ratio and amount of PANAVIA 21 Catalyst and Universal for the cementation of one full crown.  If more PANAVIA 21 paste is required, dispense an additional FULL TURN.

NOTE: PANAVIA 21 paste must always be dispensed in increments of full turns.

  1. Mix the dispensed Catalyst and Universal pastes for 20-30 seconds, creating a smooth, uniform paste.  Because of PANAVIA 21’s anaerobic properties the mix should be spread in a thin layer on the pad until ready to use.

 

 

Seating the Crown or Inlay/Onlay

  1. Apply a thin, even layer of PANAVIA 21 paste to the prepared, cleaned and dried porcelain or composite surface, being careful to avoid air entrapment. (Fig. C-7)

NOTE:  DO NOT additionally apply PANAVIA 21 paste to the tooth surface primed with ED PRIMER as this will accelerate the set of PANAVIA 21 paste.

  1. Seat the restoration and apply finger pressure.  After about 60 seconds release pressure and remove the excess PANAVIA 21 at the margins with a disposable brush tip starting first with the proximal surfaces. (Fig. C-8)
  2. With a disposable brush tip apply OXYGUARD II to the margin. (Fig. C-9) After three minutes remove the OXYGUARD II with a cotton roll and water spray.
  3. Any slight excess of PANAVIA 21 remaining at the margin can be removed with an explorer or small scaler.  The restoration can then be finished and polished with pumice and water. (Fig. C-10)

 

 

 

D. Cementation of Preformed Posts or Cast Post and Cores

 

            Treatment of Canal

  1. Remove filling material and prepare the length and diameter of the canal as appropriate for the size of post to be placed, or prepare a cast post and core. (Fig. D-1)
  2. Dispense one drop of each ED PRIMER Liquid A and Liquid B into a well of the mixing dish and mix for three-five seconds with a small sponge pledget.  Place the mixture on any coronal dentin and into the canal. (Fig. D-2) After 60 seconds evaporate the volatiles with a gentle stream of air; the surface will appear glossy.

NOTE:  Do not apply ED PRIMER to the metal.  Do not rinse.

 

 

Treatment of Preformed Post or Cast Post and Core

  1. Preformed stainless or titanium posts should be sandblasted with 30-50 micron alumina particles at an air pressure of 4.2 – 7 kg/cm2 (60-100 PSI); two to three seconds per cm2 will produce a matte finish. (Fig. D-3)
  2. Cast post and core of precious or semi-precious metal should be sandblasted as above and then tin-plated. (Fig. D-4) A layer of tin approximately 0.5 microns thick should be deposited.  To avoid contamination, do not touch the tin-plated surface.
  3. After sandblasting and after tin-plating, wash the post in a stream of water for one minute then ultrasonically clean for two-three minutes in a neutral detergent solution.

NOTE:  The prepared canal and post must be kept dry and contamination free.

 

 

Usage of PANAVIA 21 paste

  1. Remove the syringe cap and slowly rotate the dispensing knob ONE FULL TURN clockwise until it clicks.  This dispenses the proper ratio and amount of PANAVIA 21 Catalyst and Universal for the cementation of one preformed post or cast post and core.  If more PANAVIA 21 paste is required, dispense an additional FULL TURN.

NOTE: PANAVIA 21 paste must always be dispensed in increments of full turns.

  1. Mix the dispensed Catalyst and Universal pastes for 20-30 seconds, creating a smooth, uniform paste.  Because of PANAVIA 21’s anaerobic properties the mix should be spread in a thin layer on the pad until ready to use.

 

Seating the Preformed Post or Cast Post and Core

  1. Apply a thick, even layer of PANAVIA 21 paste to the prepared, cleaned and dried post, being careful to avoid air entrapment. (Fig. D-5)

NOTE:  DO NOT additionally apply PANAVIA 21 paste to the canal primed with ED PRIMER as this will accelerate the set of PANAVIA 21 paste.

  1. Seat the post and apply pressure for about 60 seconds. (Fig. D-6)
  2. If a cast post and core, remove the excess PANAVIA 21 and with a disposable brush tip apply OXYGUARD II to the margin. (Fig. D-7) After three minutes remove the OXYGUARD II with a cotton roll and water spray.
  3. If a preformed post, and amalgam or composite is being used as a build-up material, PANAVIA 21 expressed from the canal during post seating can be used as a cement for the build-up material. (Fig. D-8)
  4. Continue with normal abutment and crown procedures.

 

 

E. Bonded Amalgam Restorations

 

            Treatment of Tooth Structure

  1. Prepare the cavity in the normal manner for an amalgam restoration. (Fig. E-1) Direct pulp exposures should be covered with calcium hydroxide.  Generally there is no need for cement liners or bases.
  2. Dispense one drop of each ED PRIMER Liquid A and Liquid B into a well of the mixing dish and mix for three-five seconds.  Using a small sponge pledget, apply the mixture to both the dentin and enamel simultaneously. (Fig. E-2) After 60 seconds evaporate the volatiles with a gentle stream of air; the surface will appear glossy.

NOTE:  Do not rinse.

Usage of PANAVIA 21 paste

  1. Remove the syringe cap and slowly rotate the dispensing knob ONE FULL TURN clockwise until it clicks.  This dispenses the proper ratio and amount of PANAVIA 21 Catalyst and Universal for the cementation of a large MOD amalgam. If more PANAVIA 21 paste is required, dispense an additional FULL TURN.

NOTE:  PANAVIA 21 paste must always be dispensed in increments of full turns.

  1. Mix the dispensed Catalyst and Universal pastes for 20-30 seconds, creating a smooth, uniform paste.  Because of PANAVIA 21’s anaerobic properties the mix should be spread in a thin layer on the pad until ready to use.

 

 

Placing the Amalgam

  1. Apply a thin, even layer of PANAVIA 21 paste to the entire cavity surface primed with ED PRIMER being careful to avoid entrapping air.  (Fig. E-3)

NOTE:  Because ED PRIMER accelerates the set of PANAVIA 21, the PANAVIA 21 paste should be applied to the primed  cavity quickly.

  1. The triturated amalgam should be condensed onto the unset PANAVIA 21 paste. (Fig. E-4)
  2. Occlusal carving can be accomplished in the normal manner
  3. Remove the matrix and clean the excess PANAVIA 21 paste from the proximal surfaces with a disposable brush tip.
  4. Apply OXYGUARD II to the proximal and occlusal margins. (Fig. E-5) After three minutes remove the OXYGUARD II with a cotton roll and water spray.
  5. Any slight excess of PANAVIA 21 remaining at the margin can be removed with an explorer or a small scaler.  The restoration can then be finished in the normal manner. (Fig. E-6)

 

 

V. REPLACING PANAVIA 21 CATALYST AND UNIVERSAL PASTE SYRINGES

 

NOTE:  Refill Catalyst and Universal pastes are supplied as a set containing one syringe of Catalyst paste and one syringe of Universal EX, Universal TC or Universal OP paste.

 

            Insertion guide Syringe Cap      Bottom cover plate

            Indicator                     Flange              Flange holder

            Dispensing knob            Joint                 Clutch

 

    1. Unsnap and remove the dispenser’s bottom cover plate.
    2. The empty Catalyst and Universal paste syringes are removed together by gently pulling up on the blue joint of the syringes and lifting them out of the dispenser.
    3. Slide the clutch back toward the dispensing knob until it contacts the stop.
    4. Insert the refill Catalyst and Universal paste syringes into the dispenser.  The flange on the refill syringe fits into the flange holder of the dispenser while the blue syringe joint snaps into the rear of the clutch.
    5. Replace the dispenser bottom cover plate and affix the identifying EX, TC or OP sticker to the top of the dispenser.
    6. Slowly dispense one full turn (until you hear the click) of paste to ensure an accurate amount and ratio for the first clinical use.

 

 

Cautions and Recommendations

 

 

PANAVIA 21 HAS A SHELF LIFE OF 18 MONTHS FROM THE DATE OF MANUFACTURE WHEN KEPT REFRIGERATED.

 

CAUTION:  Federal (U.S.A.) law restricts this material to sale by or on the order of a licensed dentist.

 

WARRANTY:  Kuraray Co., Ltd. will replace any product that is proved to be defective. Kuraray Co., Ltd. does not accept liability for any loss or damage, direct, consequential or special, arising out of the application or use of  or the inability to use these products.   Before using, the user shall determine the suitability of the products for the intended use and the user assumes all risk and liability whatsoever in connection therewith.

 

NOTE: All data herein is based on research performed by Kuraray Co., Ltd. and is presented in good faith and without warranty.

CLEARFIL and PANAVIA are registered trademarks of Kuraray Co., Ltd., Osaka, Japan.

 

For technical assistance, education and training information, additional product literature or to order, please call J. Morita USA, Inc at (800) 752-9729.

 

 

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Manufactured by

KURARAY CO., LTD.

1-12-39, Umeda, Kita-ku Osaka, 530, JAPAN

To Order Please Call 1-888-277-2335