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 filed under KLE, resin tooth bonding agents. The name points to an etchant, but the record doesn't describe its use or state its formulation.
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).
Clearance details
- Applicant
- Belport Company, Inc., Gingi-Pak
- Product code
- Product 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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