Cleared Traditional

K854755 - RENAMEL ESTHETIC RESTORATIVE SYSTEM (FDA 510(k) Clearance)

K854755 · Cosmedent, Inc. · Dental device

Mar 1986

Decision

106d

Days

Class 2

Risk

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

Submitted by Cosmedent, Inc. (Chicago, US). The FDA issued a Cleared decision on March 13, 1986, 106 days after receiving the submission on November 27, 1985.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.

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	—