Cleared Traditional

K941954 - NON-FOGGING DENTAL MIRROR

K941954 is the FDA 510(k) clearance for NON-FOGGING DENTAL MIRROR by Buffalo Dental Mfg. Co., Inc.. It is a Class 1 Dental device (product code EKJ) cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K941954 · Buffalo Dental Mfg. Co., Inc. · Dental device
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Jul 1994
Decision
77d
Days
Class 1
Risk

K941954 is an FDA 510(k) clearance for the NON-FOGGING DENTAL MIRROR. Classified as Burnisher, Operative (product code EKJ), Class I - General Controls.

Submitted by Buffalo Dental Mfg. Co., Inc. (Syosset, US). The FDA issued a Cleared decision on July 8, 1994 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4565 - 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

Submission Details

510(k) Number K941954 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 22, 1994
Decision Date July 08, 1994
Days to Decision 77 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
50d faster than avg
Panel avg: 127d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EKJ Burnisher, Operative
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4565
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 - EKJ Burnisher, Operative

All 16
Devices cleared under the same product code (EKJ) and FDA review panel - the closest regulatory comparables to K941954.
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AMD DENTIST AND HYGIENIST KITS
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APPLICATOR NOZZLE
K926368 · Centrix, Inc. · Sep 1993
PART 872 DEGUFILL H & DEGUFILL M DA
K914368 · Degussa AG · Nov 1991
HARDCOATED PLASTIC FILLING INSTRUMENT
K912149 · Premier Dental Products Co. · Jun 1991