Cleared Traditional

K894281 - FIRST IMPRESSION WITH CHLORHEXIDINE

K894281 is the FDA 510(k) clearance for FIRST IMPRESSION WITH CHLORHEXIDINE by Coe Laboratories, Inc.. It is a Class 2 Dental device (product code ELW) cleared through the Traditional 510(k) pathway after a 95-day FDA review.

K894281 · Coe Laboratories, Inc. · Dental device
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Sep 1989
Decision
95d
Days
Class 2
Risk

K894281 is an FDA 510(k) clearance for the FIRST IMPRESSION WITH CHLORHEXIDINE. 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 September 26, 1989 after a review of 95 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Coe Laboratories, Inc. devices

Submission Details

510(k) Number K894281 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1989
Decision Date September 26, 1989
Days to Decision 95 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d faster than avg
Panel avg: 127d · This submission: 95d
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 K894281.
PERMADYNE GARANT LOW VISCOSITY
K896539 · Espe GmbH (Us) · Feb 1990
POLYETHER-RETARDER
K892412 · Espe GmbH (Us) · Dec 1989
PALGARAPID
K892839 · Espe GmbH (Us) · Oct 1989
RESOUND IMPRESSION MATERIAL
K892935 · Resound Corp. · Jul 1989
DICOR CERAMIC INLAY - NEW TECHNIC
K884166 · Dentsply Intl. · Apr 1989
DENTAL ALGINATE IMPRESSION MATERIAL W/ANTI. ADDI.
K883842 · Dentsply Intl. · Mar 1989