EtchPro Etching Gel— 510(k) K200462

Name: FDA 510(k) clearance K200462
Creator: U.S. Food and Drug Administration
Published: 2020-09-02

Substantially Equivalent

Belport Company, Inc., Gingi-Pak

FDA 510(k) clearance K200462 for EtchPro Etching Gel, Substantially Equivalent on 2020-09-02. Applicant: Belport Company, Inc., Gingi-Pak. Device class: 2.

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: 2020-02-25
Decision date: 2020-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Camarillo, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KLE

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K260485 — Any-Etch2026-05-14
K260430 — Porcelain Etch Gel2026-04-10
K252450 — Adhese 22026-03-05
K260682 — Bond-PR Universal Adhesive2026-03-03
K251587 — VITA VMLC Primer2026-02-23

More clearances from Belport Company, Inc., Gingi-Pak

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K251775 — RODIN Cement2025-09-02
K250279 — RC-SwiftPrep2025-07-02
K250222 — SDF Pro2025-05-07
K240688 — RODIN Titan 3D Resin2024-06-20
K231060 — ProMin Dental Desensitizing Gel2024-06-13

Data sourced from openFDA. This site is unofficial and independent of the FDA.