premier PRM-3001530 Bioactive Resin Pit and Fissure Sealant Instruction Manual

BioCoat’
Bioactive Resin Pit and Fissure Sealant

Indications for Use

BioCoat® Bioactive Pit and Fissure Sealant, a prescription-only medical device used for the prophylactic sealing of pits and fissures. It may also be used for micro-restorative or as an “initial layer” for composite restorations

Device Description:

BioCoat is a bioactive light cure resin-based pit and fissure sealant, which can also be used as an initial layer for composite restorations. BioCoat pit and fissure sealant is introduced into the occlusal pit and fissures of caries susceptible teeth, thus forming a micromechanicallybonded, protective layer cutting the access of caries-producing bacteria.

Contents:

Contraindications:

• This product contains substances that may cause an allergic reaction by skin contact in certain individuals.
• Avoid the use of this product in patients with known acrylate or fluoride allergies.
• Do not use Prophylaxis paste or pumice which contains oil prior to the use of BioCoat. This can diminish the bond strength between Biocoat and the enamel.
• Do Not use if the tooth has not been properly isolated from moisture.
• Do Not Use without etching prior to application of BioCoat

PRECAUTIONS:

• Ensure tips are securely locked to the syringe prior to use
• Disposable tips are designed for single-patient use only.
• Use personal protective equipment (PPE) during the handling of product
• Use a protective plastic sheath barrier on the syringe in order to mitigate potential cross-contamination between patient and staff.
• Do not use it after the expiration date. See the expiry date on the label.

WARNINGS:

• If prolonged contact with oral soft tissue occurs, flush with large amounts of water.
• If an allergic reaction occurs, seek medical attention as needed, remove the product if necessary and discontinue future use of the product with this patient.
• Avoid prolonged exposure to uncured product
• For use by a trained dental professional only.
• Do not use after the shelf life period indicated on product labeling/packaging.

Adverse Reactions:

• Prolonged exposure may cause skin, eye, or respiratory tract irritation.
• In rare cases, components of BioCoat may cause sensitization. In case of sensitization stop using the product.

Materials

• Contains calcium, phosphate, and fluoride
• Methacrylate base resin sealant

Instructions for Use:
Pit and Fissure Sealant:

1. Attach dispensing tip to BioCoat syringe.
2. Apply to etch to fissures for 20 seconds. Thoroughly rinse and dry. NOTE: If using sodium bicarbonate in air polishing system, repeat with a 5-second etch, thoroughly rinse and dry.
3. Upon initial use express a small drop of the BioCoat on a mixing pad prior to applying intra-orally.
4. Using the syringe needle tip or a brush, slowly introduce sealant into the pits and fissures. Do not let sealant flow beyond the etched surfaces. Stirring/agitating the sealant with the syringe tip during or immediately after placement will help eliminate any possible bubbles, and enhance the flow into the pit and fissures. An explorer may also be used. Avoid pooling of resin.
5. Light cure with a Curing Light on Standard Power (600mw/cm2) for 20 seconds for each surface. The tip of the light should be held as closely as possible to the sealant, without actually touching the sealant. When set, the sealant forms a hard, opaque film, bright white in color with a slight surface inhibition
6. Evaluate Sealant. Inspect sealant for complete coverage and voids. If the surface has not been contaminated, additional sealant may be added. If contamination has occurred re-etch, rinse, and dry prior to placing more sealant.
7. After confirming the placement of the fully cured sealant, wipe the sealant with a cotton applicator to remove the thin sticky surface film. Check occlusion and adjust as required. Note: A black light may be used for visual verification of marginal retention. Redirect overhead light when using a black light for best results.
8. Immediately after use, the dispensing tip should be removed, discarded, and the cap screwed back on to avoid prolonged air exposure.

Super Adaptive Initial Layer for Restorative:

1. Apply dentin bonding agent according to the manufacturer’s instructions.
2. Attach tip to BioCoat syringe.
3. Use a protective plastic sheath barrier on the syringe in order to mitigate potential cross-contamination between patients.
4. Verify flow prior to applying intra-orally.
5. Apply the first layer of BioCoat 0.5 – 1.5mm thick and light cure for 20 sec.
6. Follow with 2-4mm increments as needed.
7. Light cure with a curing light on Standard Power (600mw/cm2) for at least 20 seconds.
8.  For detailed anatomy, apply paste composite for the final layer. Carefully shape restorations with finishing burs and polish.

Storage and use

• Store BioCoat at room temperature (50ºF/10ºC -75ºF/24ºC).
• Avoid excess heat. Keep away from direct sunlight.
• Use only as directed, per indications for use. Tightly recap after use.
• To ensure optimal performance of the product, use immediately after dispensing and limit the amount of time of air exposure.
• Shelf life is 2 years after the date of manufacturing.

Disposal: The device should be disposed of as biohazardous medical waste in accordance with the facility or institutional guidelines/procedures.
For further information: To obtain SDS or IFU visit premierdentalco.com or call Premier at 610-239-6000.

transportation
| “CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician
| Keep away from sunlight
| Irritant (Skin and Eye) Skin Sensitizer. Acute Toxicity

Manufacturer:
Premier® Dental Products Company
1710 Romano Drive
Plymouth Meeting, PA 19462 U.S.A.
610-239-6000 • premierdentalco.com
Made in Israel

Documents / Resources

| premier PRM-3001530 Bioactive Resin Pit and Fissure Sealant [pdf] Instruction Manual
PRM-3001530, Bioactive Resin Pit and Fissure Sealant, PRM-3001530 Bioactive Resin Pit and Fissure Sealant, Resin Pit and Fissure Sealant, Fissure Sealant, Sealant
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