Cleared Traditional

K854755 - RENAMEL ESTHETIC RESTORATIVE SYSTEM

K854755 is the FDA 510(k) clearance for RENAMEL ESTHETIC RESTORATIVE SYSTEM by Cosmedent, Inc.. It is a Class 2 Dental device (product code EBF) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K854755 · Cosmedent, Inc. · Dental device
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Mar 1986
Decision
106d
Days
Class 2
Risk

K854755 is an FDA 510(k) clearance for the RENAMEL ESTHETIC RESTORATIVE SYSTEM. Classified as Material, Tooth Shade, Resin (product code EBF), Class II - Special Controls.

Submitted by Cosmedent, Inc. (Chicago, US). The FDA issued a Cleared decision on March 13, 1986 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3690 - 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 K854755 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1985
Decision Date March 13, 1986
Days to Decision 106 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 127d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EBF Material, Tooth Shade, Resin
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3690
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 - EBF Material, Tooth Shade, Resin

All 517
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K854755.
BISCO'S PORCELAIN VENEER SYSTEM
K861148 · Bisco, Inc. · Apr 1986
NUCOR COMPOSITE RESTORATIVE MATERIAL PASTE/LIQUID
K860626 · Scientific Pharmaceuticals, Inc. · Apr 1986
SCI-PHARM UNIFIL ANTERIOR/POSTERIOR LIQUID/PASTE
K860627 · Scientific Pharmaceuticals, Inc. · Mar 1986
DENTAL CEMENT
K853431 · Dentsply Intl. · Oct 1985
WUNDERSHADE
K852868 · Harry J. Bosworth Co. · Sep 1985
BISFIL-M(LIGHT CURABLE ANTERIOR COMPOSITE)
K853001 · Bisco, Inc. · Aug 1985