Cleared Traditional

K903292 - ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION ...

K903292 is the FDA 510(k) clearance for ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION ... by Coe Laboratories, Inc.. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K903292 · Coe Laboratories, Inc. · Dental device
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Oct 1990
Decision
87d
Days
Class 2
Risk

K903292 is an FDA 510(k) clearance for the ACCUFLEX/ACCUMIX VINYL POLY IMPRESSION MATERIALS. Classified as Material, Impression (product code ELW), Class II - Special Controls.

Submitted by Coe Laboratories, Inc. (Alsip, US). The FDA issued a Cleared decision on October 19, 1990 after a review of 87 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 Coe Laboratories, Inc. devices

Submission Details

510(k) Number K903292 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1990
Decision Date October 19, 1990
Days to Decision 87 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 127d · This submission: 87d
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 168
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K903292.
PERFOURM PUTTY SOFT
K910189 · Heraeus Kulzer, Inc. · Jun 1991
CUTTERSIL FUNCTION ACTIVATOR
K910360 · Heraeus Kulzer, Inc. · Jun 1991
STAT.BR TM
K904482 · Kerr Corporation (Danbury) · Nov 1990
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