Cleared Traditional

GAC THUMB-SUCKING CONTROL APPLIANCE (K920850) - FDA 510(k) Clearance

Class I Dental device.

K920850 · Gac Intl., Inc. · Dental device
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Aug 1992
Decision
181d
Days
Class 1
Risk

K920850 is an FDA 510(k) clearance for the GAC THUMB-SUCKING CONTROL APPLIANCE. Classified as Wire, Orthodontic (product code DZC), Class I - General Controls.

Submitted by Gac Intl., Inc. (Central Islip, US). The FDA issued a Cleared decision on August 24, 1992 after a review of 181 days - an extended review cycle.

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. Standard predicate reliance. 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

Submission Details

510(k) Number K920850 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1992
Decision Date August 24, 1992
Days to Decision 181 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
54d slower than avg
Panel avg: 127d · This submission: 181d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DZC Wire, 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.