PANAVIA F
DUAL CURE DENTAL ADHESIVE SYSTEM

INSTRUCTIONS FOR USE

I. INTRODUCTION

PANAVIA F is a dual-curing (chemical and light) resin based cement system for metal, composite, and silanated porcelain restorations.

PANAVIA F consists of ED PRIMER, PANAVIA F Paste, ALLOY PRIMER, and OXYGUARD II.

ED PRIMER contains HEMA and 5-NIMSA as well as MDP and consists of Liquid A and Liquid B.

PANAVIA F Paste releases fluoride.

ALLOY PRIMER improves the bond strength between precious alloy and PANAVIA F Paste. Tin plating is not required.

II. INDICATIONS

PANAVIA F is indicated for the following applications:

Cementation of metal crowns and bridges, inlays and onlays.
Cementation of porcelain crowns, inlays and onlays.
Cementation of composite resin crowns, inlays, and onlays.
Cementation of adhesion bridges.
Cementation of endodontic cores and prefabricated posts.
Amalgam bonding.

[NOTE]

Use cement shades appropriate to individual cases.

The shades of adhesive cements and applicable cases:

Cement Shade

Restoration TC White Opaque

Metal inlays and onlays; metal crowns and bridges R R ADQ

Porcelain or composite inlays, onlays and crowns R NR NR

Preformed posts and cast metal cores R R R

Adhesion bridges and splints – anterior NR ADQ R

Adhesion bridges and splints – posterior ADQ R R

Bonded amalgam restorations ADQ R ADQ

R: Recommended ADQ: Adequate NR: Not Recommended

III. CONTRAINDICATIONS

Patients with allergy to methacrylate monomers.
Patients with allergy to acetone (ALLOY PRIMER).

IV. SIDE EFFECTS

The mucous membrane may turn whitish when contacted by primer due to protein coagulation. This is a temporary phenomenon that will disappear in a few days.

V. INCOMPATIBILITY

Do not use eugenol containing materials for pulp protection and temporary sealing since they retard the curing process.

VI. PRECAUTIONS

1. Safety precautions

If any hypersensitivity such as a rash or dermatitis occurs due to contact with the product, discontinue the use of the product and consult a physician.
In order to prevent the occurrence of hypersensitivity due to contact with methacrylate monomers, acetone or acid, wear gloves or take other appropriate protective measures.
Use caution to prevent the product from coming in contact with the skin or getting into the eye. Before using the product, cover the patient’s eyes with a towel to protect the patient eyes from splashing material.
If the product comes in contact with the human body, take the following actions:

If the product gets in the eye –

Immediately wash the eye with copious amounts of water and consult a physician.

· If the product comes in contact with the skin –

Immediately wipe it off with a cotton pledget moistened with alcohol or gauze and wash off with copious amounts of water.

Use caution to prevent the patient from accidentally swallowing the product.
If a patient or operator feels sick from inhaling the acetone contained in the product, allow them to rest and breathe fresh air.
Any actual or near pulp exposure area should be covered with a hard setting calcium hydroxide material. Do not use eugenol materials for pulp protection.
When using with preformed stainless posts, the post should not contact metal restorations. Cover the post with composite resin.
Avoid looking directly at the curing light when curing the product.
Keep the product out of reach of children.

2. Handling and manipulation precautions

PANAVIA F polymerizes by visible light (especially ultraviolet rays). Use light blocking plate to avoid visible light or sunlight (including ultraviolet rays).
Make sure the disposable nozzle or disposable brush tip is securely attached to prevent the patient from swallowing them.
After placing the restoration on the tooth, the cement could cure due to the operatory light. Use caution not to let the operatory light come too close to the patient.

3. Storage precautions

Do not use after the expiration date on the outside of package.
ALLOY PRIMER is flammable. Keep away from flame.
The product should be refrigerated when not in use; bring it to room temperature before using.
Keep away from extreme heat or direct sunlight.
The bottle or syringe cap should be replaced as soon as the resin has been dispensed from the bottle or syringe. This prevents evaporation of volatile ingredients.

VII. KIT COMPONENTS

PANAVIA F consists of the following components. They are available as a set or single components.

ED PRIMER (adhesive primer) Liquid A 4ml, Liquid B 4ml

There is no need for washing after application.

PANAVIA F PASTE _ Paste A 2.3ml, Paste B 2.3ml

Paste B is available in three colors: TC, White and Opaque

ALLOY PRIMER 1ml (Refill bottle holds ml.)

This metal adhesive primer provides high bond strength to both precious and base metals
It enhances the bond strength of PANAVIA F to precious metals.

OXYGUARD II 6 ml

This Oxygene-blocking agent polymerizes the surface of the PANAVIA F Paste.

Accessories

Mixing plate, spatula, mixing paper, small brush holder, disposable brush tip, disposable nozzle, light-blocking plate.

VIII. RELATED PRODUCTS

The following products are necessary for particular procedures.

CLEARFIL PORCELAIN BOND ACTIVATOR

This product contains a silane coupling agent. To mix with CLEARFIL NEW BOND or CLEARFIL PHOTO BOND improves the bond strength to porcelain or cured composite.

CLEARFIL LINER BOND 2V

It is used to seal the cavity before cementing with PANAVIA F.
It is possible to use this material as a porcelain silanating agent by mixing primer liquids A and B and CLEARFIL PORCELAIN BOND ACTIVATOR.

K ETCHANT GEL 6ml

This phosphoric acid solution is used for pretreatment of uncut enamel and porcelain.

IX. CLINICAL PROCEDURES

1. Basic procedure (usage of adhesive cement)

[NOTE]

Use the mixed paste as soon as possible after dispensing and mixing.

1. Dispensing the pastes

1. Align marking on the nut with the reference line on the plunger and turn the syringe to dispense the necessary amount of paste. The minimum turn of the syringe should be half a turn.

2. Equal amount of paste A and paste B should be dispensed.

3. The amount of paste dispensed a last rotation of the syringe could be inaccurate. Therefore, discard the syringe before using the last portion.

4. The necessary amount of paste for typical application is:

Number of rotations of syringe Applications

Half a turn Inlays and onlays

1 turn Crowns

{NOTE}

1. If the paste is dispensed by turning the plunger a quarter of a turn, the performance of the product could be impaired when the paste hardens.

2. If not used immediately, it should be covered with a light- blocking plate.

2. Mixing paste A and paste B

Mix sufficient paste A and paste B on the mixing plate for 20 seconds. Be sure there is no water mist on the mixing plate or spatula before using them; the presence of water could shorten the working time of the mixed paste.

[CAUTION]

1. The working time of mixed paste could vary if mixing is insufficient.

2. The paste must be used within 3 minutes after mixing.

[REMARKS]

The working times of PANAVIA F Paste from dispensation to the completion of cementation are:

Working time of PANAVIA F

Working Steps Working Time

1. Dispensing the pastes 15 minutes

(by turning the syringe the same amount

of turn)

2. Mixing the paste (for 20 seconds) 3 minutes

3. Placing the restoration under pressure 40 seconds

30 sec for root canal

4. Light Curing/Applying OXYGUARD II 20 sec/Light Curing

3 min/OXYGUARD

2. Standard procedure I (Indications 1 to 4: for cementation)

The flow chart below shows the standard clinical procedure I.

Surface treatment for restoration

Treat the surface of the restoration

Cleaning abutment tooth and cavity

Clean the adherent surface to prepare for cementation

Tooth surface treatment

Treat the abutment tooth surface or the entire surface of the cavity with ED PRIMER. If the abutment is made of a precious metal alloy, apply ALLOY PRIIMER to the precious metal alloy first.

Preparing adhesive cement

Dispense the necessary amount of each paste according to the case and mix the two pastes

Placing the restoration

Apply the mix to the restoration and place it on the abutment or cavity

Removing excess cement

Remove excess cement at marginal areas

Curing adhesive cement

Cure the adhesive cement at marginal areas by using a light curing unit or applying OXYGUARD II

Finishing

Finish the restoration by polishing

(1) Surface treatment of restoration

1. Precious metals (crowns, bridges, inlays and onlays)

1. Sandblasting (as necessary)

Sandblast the restoration surface using 30-50 micron alumina particles at an air pressure of 4.2 – 7 kg/cm2 (60-100 PSI); 2-3 seconds per cm2 will remove the luster producing a matte finish.

2. Ultrasonic cleaning

Clean the restoration surface in an ultrasonic unit for 2 minutes.

3. Applying ALLOY PRIMER

Apply a thin coat of ALLOY PRIMER to the precious metal alloy.

[CAUTION]

If the adherent surface is contaminated with saliva or blood after ultrasonic cleaning, clean the adherent surface in the ultrasonic unit using a neutral detergent and then wash it for 1 minute with running water.

2. Non-precious metals

1. Sandblasting (as necessary)

Sand blast the restoration surface using 30-50 micron alumina powder at an air pressure of 4.2-7 kg/cm2 (60-100 PSI); 2-3 seconds per cm2 will remove the luster producing a matte finish.

2. Ultrasonic cleaning

Clean the restoration surface in an ultrasonic unit for 2 minutes.

[CAUTION]

If the adherent surface is contaminated with saliva or blood after ultrasonic cleaning, clean the adherent surface in an ultrasonic unit using a neutral detergent and wash it for one minute with running water.

3. Porcelain and cured composite restoration (inlays, onlays and crowns)

1. Sandblasting

Sand blast the restoration surface using 30-50 micron alumina particles at a low air pressure. (1-2 kg/cm2 (14-28 PSI)

2. Etching with phosphoric acid

Etch the adherent surface with K Etchant GEL

3. Rinse and dry

After etching with phosphoric acid, rinse the adherent surface with water and dry.

4. Coupling treatment by silane

Silanate the adherent surface using the following:

Application of the mixture of CLEARFIL PORCELAIN BOND ACTIVATOR and CLEARFIL LINER BOND 2V PRIMER (liquids A and B) or CLEARFIL PHOTO BOND or CLEARFIL NEW BOND

[NOTE]

After treating the restoration surface, proceed to cementation quickly.

(2) Adherent surface treatment

1. Cleaning cavity or abutment tooth surface

1) Remove temporary sealing agent or temporary cementation agent from the adherent surface.

2) When cementing to uncut enamel or using with adhesion bridges, apply K-ETCHANT GEL to the adherent surface for 10 seconds.

2. Adherent surface treatment

1) Mixing ED PRIMER

Dispense one drop of each Liquid A and Liquid B into well of the mixing dish and mix.

2) Applying ALLOY PRIMER

If a precious metal abutment tooth is used, apply ALLOY PRIMER to its metal surface.

[CAUTION]

If the adherent surface is contaminated with saliva or blood after ALLOY PRIMER is applied, clean the adherent surface with a cotton pledget moistened with alcohol and apply ALLOY PRIME again.

3) Applying ED PRIMER

Apply ED PRIMER to the entire tooth surface (enamel and dentin) of the adherent surface or metal or composite resin abutment tooth with a disposable brush tip or sponge and leave it in place for 60 seconds.

4) Drying

Using a sponge or paper point, remove excess primer to prevent the formation of a pool of the primer in the root canal or at the corners of the cavity. Dry the primer completely with gentle air flow. Remember that a pool of the primer will cause quick polymerization of the adhesive cement. Also do not rinse. To prevent the primer from splattering, it is good practice to dry while using a vacuum.

[CAUTION]

ED PRIMER should be applied on the entire surface of the tooth structure. Do not apply it to the restoration.

(3) Preparing PANAVIA F paste

Prepare the adhesive cement according to the basic clinical procedure.

Refer to IX.1 “basic procedure”.

(4) Cementation

1. Applying mixed paste to the restoration

Apply the mixed paste to the restoration.

[CAUTION]

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

2. Cementing restoration

Cement the restoration to the cavity or the abutment tooth.

Cementation should be completed within 40 seconds.

[CAUTION]

When the adhesive cement comes in contact with ED PRIMER, the polymerization of the adhesive cement is accelerated.

3. Removing excess paste

Any excess PANAVIA F paste 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.

4. Curing cement line

Cure the mixed paste along the cement line, using either of the following two methods.

(1) Light curing method

When it is possible to light cure adhesive cement along the cement line, such as inlays and onlays, light cure the cement line for 20 seconds. If a large surface is to be light cured, it is advisable to divide the area into several sections and light cure each section.

[CAUTION]

The Opaque paste should not be light cured but allowed to cure by using OXYGUARD II. It has a low curing depth.

(2) OXYGUARD II

Use OXYGUARD II to cure the mixed paste as follows:

With a disposable brush tip apply OXYGUARD II to the margin. After 3 minutes remove OXYGUARD II with a cotton roll and water spray.

(5) Finishing

Remove excess cement adhered to tooth surface by polishing.

3.Standard procedure II (Indication 5: core build up

[NOTE]

This procedure is for use with a preformed post and composite resin core build-up. For the cementation of metal cores, refer to standard procedure 1. And according to the instruction for use of the post and composite resin.

The flow chart below shows a typical procedure for core build up.

Surface treatment of the post

Treat the surface of the post as necessary

Cleaning the cavity and preparing an orifice of the root canal

Clean the adherent surface and prepare the root canal opening

Tooth surface treatment

Treat the tooth surface with ED PRIMER

Preparing adhesive cement

Dispense the necessary amounts of the pastes and mix them

Seating the post

Apply the mixed paste to the post and seat it in place

Light curing

Light cure the adhesive cement for 20 seconds to secure the post in place

Built-up composite resin

Built-up the composite resin for preparation of abutment

Curing and finishing composite resin

Cure the composite resin to form an abutment

(1) Surface treatment of the post

1.Sandblasting

Sand blast the post as necessary.

[NOTE]

Some preformed posts do not require sand blasting. Refer to the instruction for us of the post.

2.Applying ALLOY PRIMER

Apply ALLOY PRIMER to the post if it is precious metal alloy.

(2) Cleaning cavity and preparing root canal

Remove the temporary sealing agent from the cavity and filling material from the root canal. Using a Peesos reamer, prepare an opening for the root canal.

(3) Tooth surface treatment

Mixing ED PRIMER

Dispense one drop each of Liquid A and Liquid B on the mixing dish and mix.

Applying ED PRIMER

Using a sponge or a broach cotton, apply the mixture to the root canal, on the root surface and the tooth structure. Leave it in place for 60 seconds.

Removing excess primer (the same step is also needed in the case of metal cores)

Using a sponge, broach cotton or paper point, remove excess primer to prevent the primer from pooling at the corners of the cavity and inside the root canal.

Drying

Dry the primer with gentle air flow. It is good practice to dry while using a vacuum to prevent the primer from splattering.

[CAUTION]

Dry the primer completely. A pool of the primer at the corners of the cavity or inside the root canal will cause quick polymerization of the mixed paste.

(4) Preparing PANAVIA F paste

Prepare the adhesive cement according to the basic clinical procedure.

Refer to IX.1. “basic procedure”.

(5) Seating the post

1. Apply the mixed paste to the post

[REMARKS]

The mixed paste is applied to the metal core for cementation.

2. Seating the post into the root canal

After applying the mixed paste to the post, insert it into the root canal quickly. It is advisable to lightly vibrate the post while inserting it into the root canal to prevent the entrapment of air bubbles.

[CAUTION]

If multiple posts are to be fitted to a single tooth, use caution to prevent excess cement from flowing into other root canals.

[CAUTION]

Never use a lentulo spiral for loading the adhesive cement into the root canal. If the adhesive cement is loaded into the root canal using a composite resin syringe, the polymerization of the cement is accelerated. It is necessary to fit the post as quickly as possible.

3. Spreading excess cement

Using a small brush, spread excess cement over the remaining crown and post head.

4. Curing adhesive cement

Light cure the adhesive cement on the remaining crown and post head for 20 seconds.

[NOTE]

It is difficult to light cure if the Opaque cement is used; use the core building-up composite resin.

(6) Build-up composite resin

Build-up the composite resin for preparation of an abutment tooth according to the instruction for use.

(7) Curing and finishing of composite resin

After curing the composite resin, prepare an abutment tooth.

4. Standard procedure III (Indications 6: Amalgam Bonding)

The flow chart below shows the standard clinical procedure III.

Cleaning of tooth Structure

Clean and prepare the cavity in the normal manner for an amalgam restoration.

Treatment of tooth surface

Treat the entire cavity surface with ED PRIMER

Preparing of adhesive cement

Dispense the necessary amount of each paste according to the case and mix the two pastes.

Placing the Amalgam

Apply the mixed paste to the entire cavity surface and place the triturated amalgam into the abutment of cavity

Removing excess cement

Remove excess cement at marginal areas

Curing adhesive cement

Cure the adhesive cement at marginal areas by using a light curing unit or applying OXYGUARD II

Finishing

Finish the restoration by polishing

(1) Cleaning of tooth Structure

Cleaning cavity or abutment surface

Remove temporary sealing agent and temporary cementation agent from the adherent surface.

(2) Treatment of tooth surface

Treating with ED PRIMER

1. Preparing with ED PRIMER

Dispense one drop each of Liquid A and Liquid B on the mixing plate and mix.

2. Applying ED PRIMER

Apply ED PRIMER to the entire adherent tooth surface (enamel and dentin), metal, or composite resin abutment with a small brush or sponge and leave it in place for 60 seconds.

3. Drying

Using a sponge or paper point, remove excess primer to prevent the primer from pooling in the root canal or at the corners of the cavity. Dry the primer completely by using gentle air flow. Remember that a pool of the primer will cause quick polymerization of the adhesive cement. To prevent the primer from splashing, it is good practice to dry while using a vacuum.

(3) Preparing of adhesive cement

Prepare the adhesive according to the basic clinical procedure. Refer to IX.1. “basic procedure”.

(4) Placing the Amalgam

1. Apply the adhesive cement to the cavity

Apply a thin, even layer of the mixed adhesive cement to the entire cavity surface primed with ED PRIMER being careful to avoid entrapping air.

[CAUTION]

Because ED PRIMER accelerates the set of the adhesive cement, the adhesive cement should be applied to the primed cavity quickly.

2. Amalgam filling

The triturated amalgam should be condensed on the unset adhesive cement.

Occlusal carving can be accomplished in the normal manner.

(5) Removing excess cement

Any slight excess of PANAVIA F paste 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.

(6) Curing adhesive cement

Cure the mixed paste along the cement line, using either of the following two methods.

1. Light curing method

[CAUTION]

The Opaque paste should not be light cured but allowed to cure by using OXYGUARD II. It has a low curing depth.

2. OXYGUARD II

Use OXYGUARD II to cure the mixed paste as follows:

With a disposable brush tip apply OXYGUARD II to the margin. After minutes remove OXYGUARD II with a cotton roll and water spray.

(7) Finishing

Remove excess cement adhered to tooth structure by polishing.

[CAUTION]

Federal (U.S.A.) law restricts this device 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]

CLEARFIL and PANAVIA are trademarks of

KURARAY CO., LTD.

Manufactured by

KURARARY CO., LTD.

1-12-39, Umeda, Kita-ku, Osaka 530-8611, Japan

To Order Please Call 1-888-277-2335