Cleared Traditional

INSURE PORCELAIN VENEER BONDING SYSTEM (K873356) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

Device Classification

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 504
Devices cleared under the same product code (EMA) and FDA review panel - the closest regulatory comparables to K873356.
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