Cleared Traditional

K942668 - O-TRAY IMPRESSION TRAYS

K942668 is an FDA 510(k) clearance for O-TRAY IMPRESSION TRAYS, manufactured by Dentauraum, Inc.. The device is a Class 1 Dental device with product code EHY cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K942668 · Dentauraum, Inc. · Dental device
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Jul 1994
Decision
46d
Days
Class 1
Risk

K942668 is an FDA 510(k) clearance for the O-TRAY IMPRESSION TRAYS. Classified as Tray, Impression, Preformed (product code EHY), Class I - General Controls.

Submitted by Dentauraum, Inc. (Newtown, US). The FDA issued a Cleared decision on July 22, 1994 after a review of 46 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6880 - 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 Dentauraum, Inc. devices

FDA 510(k) Submission Details - K942668

510(k) Number K942668 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 06, 1994
Decision Date July 22, 1994
Days to Decision 46 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
81d faster than avg
Panel avg: 127d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

EHY Device Classification - Class 1, General Controls

Product Code EHY Tray, Impression, Preformed
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6880
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 - EHY Tray, Impression, Preformed

Devices cleared under the same product code (EHY) and FDA review panel - the closest regulatory comparables to K942668.
EOS IMPRESSION TRAYS
K896470 · Ivoclar North America, Inc. · Feb 1990
SR-IVOTRAY SPECIAL
K810524 · J. Aderer, Inc. · Mar 1981
SR-IVOTRAY UNIVERSAL
K810525 · J. Aderer, Inc. · Mar 1981
PERF-LOCK IMPRESSION TRAY
K801548 · Dentsply Intl. · Jul 1980
PREMIER TRIPLE TRAY
K800900 · Premier Dental Products Co. · Apr 1980
4-IN-1 DISP. CROWN & BRIDGE TRAY
K780211 · Kerr Corporation (Danbury) · Feb 1978