Cleared Traditional

EtchPro Etching Gel

K200462 · Belport Company, Inc., Gingi-Pak · Dental
Sep 2020
Decision
190d
Days
Class 2
Risk

About This 510(k) Submission

K200462 is an FDA 510(k) clearance for the EtchPro Etching Gel, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Belport Company, Inc., Gingi-Pak (Camarillo, US). The FDA issued a Cleared decision on September 2, 2020, 190 days after receiving the submission on February 25, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K200462 FDA.gov
FDA Decision Cleared SESE
Date Received February 25, 2020
Decision Date September 02, 2020
Days to Decision 190 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200