BRITESMILE BARRIER MATERIAL— 510(k) K010935

Substantially Equivalent

Britesmile, Inc.

FDA 510(k) clearance K010935 for BRITESMILE BARRIER MATERIAL, Substantially Equivalent on 2001-09-05. Applicant: Britesmile, Inc.. Device class: 1.

Clearance details

Applicant: Britesmile, Inc.
Product code: Code EIE
Device class: Class 1
Regulation: 21 CFR 872.6300
Advisory panel: Dental
Date received: 2001-03-28
Decision date: 2001-09-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIE

K182118 — armor LC2019-05-03
K151945 — Triumph Resin Dam2016-02-18
K050318 — BARI-KAD PACKING DEVICE2005-03-04
K043301 — GC TION GINGIVAL PROTECTOR2005-01-25
K040797 — BRITESMILE MASKING CREAM2004-04-02

Data sourced from openFDA. This site is unofficial and independent of the FDA.