Identifiers
- 510(k) Number
- K901049 FDA 510(k)
- FDA Product Code
- LBH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3260 FDA 510(k)
- Regulation Number
- 872.3260 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Copal Varnish is a dental cavity varnish, classified under the product code LBH. It is designed to be applied to prepared tooth surfaces to protect dentin and promote bonding in restorative procedures, helping to reduce postoperative sensitivity and improve longevity of dental restorations.
This product is supplied as a single-use dental material and is intended for use in dental offices. It is regulated under FDA 510(k) clearance (K901049) with a decision of Substantially Equivalent (SESE) under regulation 872.3260. The device is non-sterile and must be stored in a cool, dry place away from direct sunlight until use.
Frequently asked questions
What is Copal Varnish primarily used for in dental procedures?
Copal Varnish is designed to protect dentin and promote bonding during restorative dental procedures. It is applied to prepared tooth surfaces to help reduce postoperative sensitivity and improve the longevity of dental restorations, ensuring better adhesion of filling materials.
Is Copal Varnish intended for single-use or can it be reused?
Copal Varnish is explicitly supplied as a single-use dental material, meaning each application should use a new unit. This ensures sterility and safety for the patient, as reuse is not recommended or supported by its design.
How should Copal Varnish be stored before use?
Copal Varnish must be stored in a cool, dry place away from direct sunlight. This helps maintain its integrity and effectiveness, as exposure to heat or moisture could compromise its performance.
Is Copal Varnish sterile, and if not, what precautions should be taken?
Copal Varnish is non-sterile, so it should be handled in a manner consistent with standard dental practice for non-sterile materials. Clinicians should follow proper aseptic techniques to minimize contamination before application.
What regulatory pathway was followed for Copal Varnish’s FDA clearance?
Copal Varnish received FDA clearance through a 510(k) submission (K901049) under the Traditional clearance type, with a decision of Substantially Equivalent (SESE) to a predicate device. The product is classified under product code LBH and falls under the Dental advisory committee (DE).
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: COPAL VARNISH (K901049) — FDA 510 (k) | Innolitics, K100503 - PULPDENT COPAL VARNISH WITH FLUORIDE | FDA 510 (k), COPAL VARNISH 510 (k) K901049 - FDA.report, K100503 - PULPDENT COPAL VARNISH WITH FLUORIDE | FDA 510 (k)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K901049 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K901049 24 fields · synced Sep 18, 2026