Cleared Traditional

K932319 - ORTHODONTIC ELASTOMER

K932319 is an FDA 510(k) clearance for ORTHODONTIC ELASTOMER, manufactured by Gac Intl., Inc.. The device is a Class 1 Dental device with product code ECI cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K932319 · Gac Intl., Inc. · Dental device
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Sep 1993
Decision
132d
Days
Class 1
Risk

K932319 is an FDA 510(k) clearance for the ORTHODONTIC ELASTOMER. Classified as Band, Elastic, Orthodontic (product code ECI), Class I - General Controls.

Submitted by Gac Intl., Inc. (Central Islip, US). The FDA issued a Cleared decision on September 20, 1993 after a review of 132 days - within the typical 510(k) review window.

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

FDA 510(k) Submission Details - K932319

510(k) Number K932319 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1993
Decision Date September 20, 1993
Days to Decision 132 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
5d slower than avg
Panel avg: 127d · This submission: 132d
Pathway characteristics
Predicate-based equivalence.

ECI Device Classification - Class 1, General Controls

Product Code ECI Band, Elastic, 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 - ECI Band, Elastic, Orthodontic

All 7
Devices cleared under the same product code (ECI) and FDA review panel - the closest regulatory comparables to K932319.
GLENROE GLOW IN DARK ELASTOMERIC LIGATURES
K973495 · Glenroe · Dec 1997
ALASTIK
K940165 · Unitek Corp. · Mar 1994
DENTAURUM OLYMPIA LATEX-ELASTICS AND DENTAURUM LATEX-ELASTICS
K935144 · Dentauraum, Inc. · Feb 1994
ALASTIK NS
K923999 · Unitek Corp. · Jun 1993
UNI-STICK PLASTIC LIGATURE, MODIFIED
K926578 · American Orthodontics · Mar 1993