Cleared Traditional

HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT (K943334) - FDA 510(k) Clearance

Class I Dental device.

K943334 · Jay H. Geller · Dental device
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Oct 1994
Decision
85d
Days
Class 1
Risk

K943334 is an FDA 510(k) clearance for the HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT. Classified as Wire, Orthodontic (product code DZC), Class I - General Controls.

Submitted by Jay H. Geller (Santa Monica, US). The FDA issued a Cleared decision on October 5, 1994 after a review of 85 days - a notably fast clearance 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: 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 Jay H. Geller devices

Submission Details

510(k) Number K943334 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1994
Decision Date October 05, 1994
Days to Decision 85 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
42d faster than avg
Panel avg: 127d · This submission: 85d
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.