Cleared Traditional

K920784 - ORTHODONTIC FACE BOW W/ INNER WIRE

K920784 is the FDA 510(k) clearance for ORTHODONTIC FACE BOW W/ INNER WIRE by Gac Intl., Inc.. It is a Class 2 Dental device (product code DZB) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K920784 · Gac Intl., Inc. · Dental device
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Mar 1992
Decision
29d
Days
Class 2
Risk

K920784 is an FDA 510(k) clearance for the ORTHODONTIC FACE BOW W/ INNER WIRE. Classified as Headgear, Extraoral, Orthodontic (product code DZB), Class II - Special Controls.

Submitted by Gac Intl., Inc. (Central Islip, US). The FDA issued a Cleared decision on March 20, 1992 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5500 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gac Intl., Inc. devices

Submission Details

510(k) Number K920784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1992
Decision Date March 20, 1992
Days to Decision 29 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
98d faster than avg
Panel avg: 127d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DZB Headgear, Extraoral, Orthodontic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5500
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - DZB Headgear, Extraoral, Orthodontic

Devices cleared under the same product code (DZB) and FDA review panel - the closest regulatory comparables to K920784.
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