Identifiers
- 510(k) Number
- K896655 FDA 510(k)
- FDA Product Code
- KLE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3200 FDA 510(k)
- Regulation Number
- 872.3200 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Porcelain Etching Agent (FDA classification: Agent, Tooth Bonding, Resin) designed to chemically etch porcelain surfaces. It contains 9.6% hydrofluoric acid to create micro-retentive patterns on porcelain crowns, veneers, inlays, and fractured porcelain prior to bonding procedures, improving adhesion of resin-based materials.
The gel is supplied in a thixotropic 1.2 mL syringe, packaged as four units per box. It is intended for single-use in dental settings and requires no sterilisation. The device has received FDA 510(k) clearance under the classification of Class II medical devices (regulation number 872.3200) and is regulated under dental specialty guidelines. No MRI safety information is specified.
Frequently asked questions
What is the primary purpose of the 9.6% Hydrofluoric Acid Gel in dental procedures?
The 9.6% Hydrofluoric Acid Gel is specifically designed to chemically etch porcelain surfaces, creating micro-retentive patterns on porcelain crowns, veneers, inlays, and fractured porcelain. This process improves the adhesion of resin-based materials during bonding procedures, ensuring a stronger bond.
How is the 9.6% Hydrofluoric Acid Gel supplied, and is it reusable?
The gel comes in a thixotropic 1.2 mL syringe, with each box containing four individual units. It is explicitly intended for single-use only in dental settings, so reuse is not recommended or supported by the manufacturer.
Does this product require sterilization before use, and how should it be stored?
No sterilization is required before use, as the gel is designed for single-use applications. Storage conditions are not explicitly detailed in the provided data, but typical dental chemicals should be kept in a cool, dry place, away from direct sunlight and protected from extreme temperatures.
What regulatory pathway was followed for FDA clearance of this device?
The 9.6% Hydrofluoric Acid Gel received FDA 510(k) clearance under the classification of Class II medical devices (regulation number 872.3200), with a decision described as *Substantially Equivalent*. The submission was reviewed by the Dental (DE) Advisory Committee and filed under the Traditional clearance type, indicating a direct comparison to a predicate device.
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: Porcelain Etch Gel - PULPDENT, PEG Porcelain Etching Gel - Henry Schein Dental, Porcelain Etch Gel 9.6% Hydrofluoric Acid (Pulpdent)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K896655 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K896655 24 fields · synced Sep 18, 2026