Cleared Traditional

K841323 - FUZZY TRAY

K841323 is an FDA 510(k) clearance for FUZZY TRAY, manufactured by Buffalo Dental Mfg. Co., Inc.. The device is a Class 1 Dental device with product code EHY cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K841323 · Buffalo Dental Mfg. Co., Inc. · Dental device
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Jun 1984
Decision
86d
Days
Class 1
Risk

K841323 is an FDA 510(k) clearance for the FUZZY TRAY. Classified as Tray, Impression, Preformed (product code EHY), Class I - General Controls.

Submitted by Buffalo Dental Mfg. Co., Inc. (Mchenry, US). The FDA issued a Cleared decision on June 27, 1984 after a review of 86 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 Buffalo Dental Mfg. Co., Inc. devices

FDA 510(k) Submission Details - K841323

510(k) Number K841323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 1984
Decision Date June 27, 1984
Days to Decision 86 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
41d faster than avg
Panel avg: 127d · This submission: 86d
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

All 7
Devices cleared under the same product code (EHY) and FDA review panel - the closest regulatory comparables to K841323.
O-TRAY IMPRESSION TRAYS
K942668 · Dentauraum, Inc. · Jul 1994
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