Cleared Traditional

K904128 - PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER

K904128 is an FDA 510(k) clearance for PERFORMED TEMPLATE W/FRAGRANCE FOR TOOT..., manufactured by American Orthodontics. The device is a Class 1 Dental device with product code KMY cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K904128 · American Orthodontics · Dental device
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Nov 1990
Decision
65d
Days
Class 1
Risk

K904128 is an FDA 510(k) clearance for the PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER. Classified as Positioner, Tooth, Preformed (product code KMY), Class I - General Controls.

Submitted by American Orthodontics (Sheboygan, US). The FDA issued a Cleared decision on November 9, 1990 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5525 - 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 - K904128

510(k) Number K904128 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1990
Decision Date November 09, 1990
Days to Decision 65 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 128d · This submission: 65d
Pathway characteristics
Predicate-based equivalence.

KMY Device Classification - Class 1, General Controls

Product Code KMY Positioner, Tooth, Preformed
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5525
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 - KMY Positioner, Tooth, Preformed

All 11
Devices cleared under the same product code (KMY) and FDA review panel - the closest regulatory comparables to K904128.
RELAX-O-GUARD
K925064 · Aquatemp Service Co., Inc. · Sep 1993
THE ORTHOTRAINER
K924975 · Myofunctional Research Corp. Pty. , Ltd. · Jul 1993
THE TMJ APPLIANCE
K924974 · Myofunctional Research Corp. Pty. , Ltd. · Jun 1993
PREFORMED TEMPLATE FOR TOOTH POSITIONER
K891328 · American Orthodontics · Mar 1989
REMOLDABLE CRANIOMANDIBULAR APPLIANCE
K833455 · Jeffrey H. Attlin · Jan 1984
AQUALIZER MOUTHPIECE
K831793 · Martin D. Lerman · Aug 1983
K904128 · PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER
Download PDF American Orthodontics