Cleared Special

BRITESMILE MASKING CREAM

K040797 · Britesmile, Inc. · Dental
Apr 2004
Decision
4d
Days
Class 1
Risk

About This 510(k) Submission

K040797 is an FDA 510(k) clearance for the BRITESMILE MASKING CREAM, a Dam, Rubber (Class I — General Controls, product code EIE), submitted by Britesmile, Inc. (North Attleboro, US). The FDA issued a Cleared decision on April 2, 2004, 4 days after receiving the submission on March 29, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.6300.

Submission Details

510(k) Number K040797 FDA.gov
FDA Decision Cleared SESE
Date Received March 29, 2004
Decision Date April 02, 2004
Days to Decision 4 days
Submission Type Special
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EIE — Dam, Rubber
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6300