Porcelain Etch Gel— 510(k) K260430
Substantially EquivalentBelport Company, Inc., Gingi-Pak
FDA 510(k) clearance K260430 for Porcelain Etch Gel, Substantially Equivalent on 2026-04-10. Applicant: Belport Company, Inc., Gingi-Pak. Device class: 2.
Summary
Porcelain Etch Gel is a dental etchant for preparing porcelain restorations before bonding. Porcelain etchants are usually hydrofluoric acid gels, though the record doesn't state this one's formulation. It's filed under KLE, resin tooth bonding agents.
Class II, 21 CFR 872.3200. The Dental panel reviewed it as a Traditional 510(k).
Belport Company (Gingi-Pak) filed from Camarillo, California. Review took 59 days (February 10 to April 10, 2026). Dental materials in mature codes like this one tend to clear quickly.
Clearance details
- Applicant
- Belport Company, Inc., Gingi-Pak
- Product code
- Code KLE
- Device class
- Class 2
- Regulation
- 21 CFR 872.3200
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Camarillo, CA, US
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