Cleared Traditional

MICROARCH GOLD BRACKET

K932825 · Gac Intl., Inc. · Dental
May 1994
Decision
334d
Days
Class 1
Risk

About This 510(k) Submission

K932825 is an FDA 510(k) clearance for the MICROARCH GOLD BRACKET, a Bracket, Metal, Orthodontic (Class I — General Controls, product code EJF), submitted by Gac Intl., Inc. (Central Islip, US). The FDA issued a Cleared decision on May 9, 1994, 334 days after receiving the submission on June 9, 1993. This device falls under the Dental review panel. Regulated under 21 CFR 872.5410.

Submission Details

510(k) Number K932825 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 1993
Decision Date May 09, 1994
Days to Decision 334 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EJF — Bracket, Metal, Orthodontic
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.5410