BRITESMILE MASKING CREAM

Dam, Rubber

BRITESMILE, INC.

The following data is part of a premarket notification filed by Britesmile, Inc. with the FDA for Britesmile Masking Cream.

Pre-market Notification Details

Device IDK040797
510k NumberK040797
Device Name:BRITESMILE MASKING CREAM
ClassificationDam, Rubber
Applicant BRITESMILE, INC. 49 PLAIN ST. North Attleboro,  MA  02760
ContactSheila Hemeon-heyer
CorrespondentSheila Hemeon-heyer
BRITESMILE, INC. 49 PLAIN ST. North Attleboro,  MA  02760
Product CodeEIE  
CFR Regulation Number872.6300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2004-03-29
Decision Date2004-04-02

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.