Cleared Traditional

K873356 - INSURE PORCELAIN VENEER BONDING SYSTEM

K873356 is an FDA 510(k) clearance for INSURE PORCELAIN VENEER BONDING SYSTEM, 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 131-day FDA review.

K873356 · Cosmedent, Inc. · Dental device
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Dec 1987
Decision
131d
Days
Class 2
Risk

K873356 is an FDA 510(k) clearance for the INSURE PORCELAIN VENEER BONDING 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 December 29, 1987 after a review of 131 days - within the typical 510(k) review window.

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 - K873356

510(k) Number K873356 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 1987
Decision Date December 29, 1987
Days to Decision 131 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
4d slower than avg
Panel avg: 127d · This submission: 131d
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 421
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K873356.
KETAC-CONDITIONER
K872984 · Espe GmbH (Us) · Mar 1988
CEMENT LINER
K874945 · Dentsply Intl. · Feb 1988
GLASS IONOMERS-BIO-GLASS BASE/LINING & LUTING CEM.
K874500 · Harry J. Bosworth Co. · Feb 1988
LIGHT-CURED PERIODONTAL DRESSING
K864720 · Dentsply Intl. · Apr 1987
BONDEX* GLASS IONOMER CEMENT
K870211 · Johnson & Johnson Professionals, Inc. · Mar 1987
BOSTON POST CEMENT
K870334 · Scientific Pharmaceuticals, Inc. · Feb 1987