Cleared Traditional

K904482 - STAT.BR TM

K904482 is the FDA 510(k) clearance for STAT.BR TM by Kerr Corporation (Danbury). It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K904482 · Kerr Corporation (Danbury) · Dental device
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Nov 1990
Decision
58d
Days
Class 2
Risk

K904482 is an FDA 510(k) clearance for the STAT.BR TM. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Kerr Corporation (Danbury) (Romulus, US). The FDA issued a Cleared decision on November 29, 1990 after a review of 58 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3660 - 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 Kerr Corporation (Danbury) devices

Submission Details

510(k) Number K904482 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 1990
Decision Date November 29, 1990
Days to Decision 58 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
69d faster than avg
Panel avg: 127d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code ELW Material, Impression
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - ELW Material, Impression

All 156
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K904482.
CUTTERSIL XL
K910166 · Heraeus Kulzer, Inc. · Jun 1991
PERFOURM PUTTY SOFT
K910189 · Heraeus Kulzer, Inc. · Jun 1991
CUTTERSIL FUNCTION ACTIVATOR
K910360 · Heraeus Kulzer, Inc. · Jun 1991
DEGUFLEX (R) CS LIGHT
K901866 · Degussa AG · Sep 1990
DEGUFLEX MONOPHASE
K901865 · Degussa AG · Sep 1990
DEGUFLEX (R) CS PUTTY
K901867 · Degussa AG · Sep 1990