Bisco Porcelain Etching Gel
FDA 510(k)Class II (US FDA 510(k))
by Bisco Inc.
Identifiers
- 510(k) Number
- K926238 FDA 510(k)
- FDA Product Code
- EIH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.6660 FDA 510(k)
- Regulation Number
- 872.6660 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bisco Porcelain Etching Gel is a dental adhesive preparation designed to condition porcelain surfaces. It contains hydrofluoric acid to microscopically roughen feldspathic porcelain or glass, increasing surface area for improved bonding with dental cements or resin materials. This process enhances adhesion strength, mimicking the effects of sandblasting but with greater precision and control. The gel is classified as a dental etchant under regulatory nomenclature.
This gel is supplied in two concentrations—9.5% and 4%—and is intended for single-use in clinical settings. It requires careful handling due to its corrosive properties and must be used in accordance with dental protocols. The product is FDA-cleared under a 510(k) submission (K926238) and falls under the Dental (DE) advisory committee category. Sterility and packaging details are not specified in the regulatory data, but standard dental practice dictates it should be used aseptically in a controlled environment.
Frequently asked questions
What is the Bisco Porcelain Etching Gel used for?
The Bisco Porcelain Etching Gel is designed to condition feldspathic porcelain or glass surfaces by microscopically roughening them. This process increases the surface area, allowing dental cements or resin materials to bond more effectively—similar to sandblasting but with greater precision. The gel’s hydrofluoric acid content enables controlled etching, enhancing adhesion strength for restorative procedures.
How is the Bisco Porcelain Etching Gel supplied, and what concentrations are available?
The gel is supplied in two concentrations: 9.5% and 4%. These concentrations cater to different clinical needs, with the higher percentage offering stronger etching for tougher porcelain surfaces. The product is intended for single-use in clinical settings, requiring careful handling due to its corrosive properties.
Is the Bisco Porcelain Etching Gel sterile, and how should it be stored?
Regulatory data does not specify sterility details, but standard dental practice recommends using the gel aseptically in a controlled environment. Since it is single-use, unopened gel should be stored in a cool, dry place, protected from direct light and moisture. Always follow manufacturer guidelines for optimal shelf life and safety.
Can the Bisco Porcelain Etching Gel be reused, and what safety precautions should be taken?
The gel is intended for single-use only to maintain efficacy and prevent contamination. Due to its corrosive hydrofluoric acid content, it requires careful handling—use nitrile gloves, eye protection, and proper ventilation. Avoid skin contact, and rinse thoroughly with water if accidental exposure occurs. Follow dental protocols for disposal to ensure safety.
What regulatory approval does the Bisco Porcelain Etching Gel hold, and under which committee was it reviewed?
The gel holds FDA 510(k) clearance under submission K926238, classified as substantially equivalent to a predicate device. It was reviewed by the Dental (DE) Advisory Committee in 1993, with a decision date of March 31, 1993. The product falls under the Dental (DE) advisory committee category and the EIH product code for dental etchants.
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 Etchant Hydrofluoric Acid Gel | BISCO, Shop All Categories - Dental Etchants - BISCO Inc., Porcelain Etchant™-Bisco-USA | Porcelain Surface Conditioner, Porcelain dental material - Porcelain Etchant - BISCO - resin / for ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K926238 | Class II | Active |
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Manufacturer
- Manufacturer
- Bisco Inc.
- FDA Applicant
- Bisco, Inc.
Sources (1)
- FDA 510(k) K926238 24 fields · synced Oct 1, 2026