Cleared Traditional

K943334 - HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT

K943334 is an FDA 510(k) clearance for HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT, manufactured by Jay H. Geller. The device is a Class 1 Dental device with product code DZC cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K943334 · Jay H. Geller · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K943334

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
43d faster than avg
Panel avg: 128d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

DZC Device Classification - Class 1, General Controls

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.

Regulatory Peers - DZC Wire, Orthodontic

All 21
Devices cleared under the same product code (DZC) and FDA review panel - the closest regulatory comparables to K943334.
HYPERELASTIC WIRE
K112640 · Ormco Corp. · Nov 2011
NITINOL, NITI
K935638 · Highland Metals · May 1994
DENTAURUM STEEL LIGATURE WIRES
K935140 · Dentauraum, Inc. · Feb 1994
DENTAURUM WIRES
K935142 · Dentauraum, Inc. · Jan 1994
FLEXMEDICS SUPER-SEVEN STRANDED NICKEL-TITANIUM ARCHWIRE
K934265 · Flexmedics · Jan 1994
NITI COIL SPRINGS
K933374 · Highland Metals · Nov 1993
K943334 · HAWLEY RETAINER ORTHODONTIC APPLICANCE KIT
Download PDF Jay H. Geller