Cleared Traditional

MESIAL LOOP BAR (K933542) - FDA 510(k) Clearance

Class I Dental device.

K933542 · Gac Intl., Inc. · Dental device
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Aug 1994
Decision
381d
Days
Class 1
Risk

K933542 is an FDA 510(k) clearance for the MESIAL LOOP BAR. Classified as Spring, Orthodontic (product code ECO), Class I - General Controls.

Submitted by Gac Intl., Inc. (Central Islip, US). The FDA issued a Cleared decision on August 5, 1994 after a review of 381 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

Submission Details

510(k) Number K933542 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 20, 1993
Decision Date August 05, 1994
Days to Decision 381 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
254d slower than avg
Panel avg: 127d · This submission: 381d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code ECO Spring, 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.