Cleared Traditional

K932825 - MICROARCH GOLD BRACKET

K932825 is an FDA 510(k) clearance for MICROARCH GOLD BRACKET, manufactured by Gac Intl., Inc.. The device is a Class 1 Dental device with product code EJF cleared through the Traditional 510(k) pathway after a 334-day FDA review.

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

K932825 is an FDA 510(k) clearance for the MICROARCH GOLD BRACKET. Classified as Bracket, Metal, Orthodontic (product code EJF), Class I - General Controls.

Submitted by Gac Intl., Inc. (Central Islip, US). The FDA issued a Cleared decision on May 9, 1994 after a review of 334 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5410 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Gac Intl., Inc. devices

FDA 510(k) Submission Details - K932825

510(k) Number K932825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
207d slower than avg
Panel avg: 127d · This submission: 334d
Pathway characteristics
Predicate-based equivalence.

EJF Device Classification - Class 1, General Controls

Product Code EJF Bracket, Metal, Orthodontic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5410
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - EJF Bracket, Metal, Orthodontic

All 47
Devices cleared under the same product code (EJF) and FDA review panel - the closest regulatory comparables to K932825.
BITEM LOCK, MODELS SW006, SW012
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ALASTIK
K933501 · Unitek Corp. · Apr 1994
FASCINATION CERAMIC BRACKET
K935139 · Dentauraum, Inc. · Feb 1994
DENTAURUM METAL BRACKETS
K935122 · Dentauraum, Inc. · Jan 1994
ORMCO SPORTSGUARD
K922806 · Ormco Corp. · Oct 1993
PLASTIC CHAIN
K925012 · American Orthodontics · Sep 1993