Cleared Traditional

K854755 - RENAMEL ESTHETIC RESTORATIVE SYSTEM

K854755 is an FDA 510(k) clearance for RENAMEL ESTHETIC RESTORATIVE SYSTEM, manufactured by Cosmedent, Inc.. The device is a Class 2 Dental device with 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

FDA 510(k) Submission Details - K854755

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
Combination Product No
PCCP Authorized No
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.

EBF Device Classification - Class 2, Special Controls

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 782
Devices cleared under the same product code (EBF) and FDA review panel - the closest regulatory comparables to K854755.
PHOTO CLEARFIL OPAQUER
K860708 · Kuraray Co. · 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