Cleared Traditional

K894477 - INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEM

K894477 is an FDA 510(k) clearance for INSURE MATCH MATE PORCELAIN VENEER TRY-..., manufactured by Cosmedent, Inc.. The device is a Class 2 Dental device with product code EMA cleared through the Traditional 510(k) pathway after a 176-day FDA review.

K894477 · Cosmedent, Inc. · Dental device
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Jan 1990
Decision
176d
Days
Class 2
Risk

K894477 is an FDA 510(k) clearance for the INSURE MATCH MATE PORCELAIN VENEER TRY-IN SYSTEM. Classified as Cement, Dental (product code EMA), Class II - Special Controls.

Submitted by Cosmedent, Inc. (Chicago, US). The FDA issued a Cleared decision on January 10, 1990 after a review of 176 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3275 - 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 Cosmedent, Inc. devices

FDA 510(k) Submission Details - K894477

510(k) Number K894477 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 1989
Decision Date January 10, 1990
Days to Decision 176 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
49d slower than avg
Panel avg: 127d · This submission: 176d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EMA Device Classification - Class 2, Special Controls

Product Code EMA Cement, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3275
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 - EMA Cement, Dental

All 433
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K894477.
GRANITEC Z2, ZINC PHOSPHATE CEMENT
K896649 · Confi-Dental Products Co. · Feb 1990
GRANITEC P2 AND GRANITEC G2 DENTAL CEMENTS
K894953 · Confi-Dental Products Co. · Feb 1990
BANDTITE GLASS IONOMER CEMENT
K896249 · American Orthodontics · Jan 1990
SILCOT COPAL CAVITY VARNISH
K895798 · Specialites Septodont · Dec 1989
KULZER GLAS-IONOMER CEMENT
K892453 · Kulzer, Inc. · Dec 1989
TEMP BOND NE
K894219 · Kerr Corporation (Danbury) · Sep 1989