Cleared Traditional

K010935 - BRITESMILE BARRIER MATERIAL
(FDA 510(k) Clearance)

K010935 · Britesmile, Inc. · Dental device

Sep 2001

Decision

161d

Days

Class 1

Risk

K010935 is an FDA 510(k) clearance for the BRITESMILE BARRIER MATERIAL. This device is classified as a Dam, Rubber (Class I - General Controls, product code EIE).

Submitted by Britesmile, Inc. (North Attleboro, US). The FDA issued a Cleared decision on September 5, 2001, 161 days after receiving the submission on March 28, 2001.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6300.

Submission Details

510(k) Number	K010935 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 28, 2001
Decision Date	September 05, 2001
Days to Decision	161 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF