Cleared Traditional

K894282 - FIRST IMPRESSION TM

K894282 is an FDA 510(k) clearance for FIRST IMPRESSION TM, manufactured by Coe Laboratories, Inc.. The device is a Class 2 Dental device with product code ELW cleared through the Traditional 510(k) pathway after a 182-day FDA review.

K894282 · Coe Laboratories, Inc. · Dental device
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Dec 1989
Decision
182d
Days
Class 2
Risk

K894282 is an FDA 510(k) clearance for the FIRST IMPRESSION TM. 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 December 22, 1989 after a review of 182 days - an extended review 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: 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

FDA 510(k) Submission Details - K894282

510(k) Number K894282 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 23, 1989
Decision Date December 22, 1989
Days to Decision 182 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
55d slower than avg
Panel avg: 127d · This submission: 182d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ELW Device Classification - Class 2, Special Controls

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 322
Devices cleared under the same product code (ELW) and FDA review panel - the closest regulatory comparables to K894282.
FORMASIL(R)A POLYVINYL SILOXANE LINE
K901681 · Kulzer, Inc. · Jun 1990
EOS BLUEPHASE-P AND REDPHASE-P IMPRESSION MATERIAL
K896468 · Ivoclar North America, Inc. · Apr 1990
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
FIRST IMPRESSION WITH CHLORHEXIDINE
K894281 · Coe Laboratories, Inc. · Sep 1989