BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101— 510(k) K063704

Name: FDA 510(k) clearance K063704
Creator: U.S. Food and Drug Administration
Published: 2007-02-20

Substantially Equivalent

Beks Incorporated

FDA 510(k) clearance K063704 for BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101, Substantially Equivalent on 2007-02-20. Applicant: Beks Incorporated. Device class: 1.

Clearance details

Applicant: Beks Incorporated
Product code: Code EEG
Device class: Class 1
Regulation: 21 CFR 872.6475
Advisory panel: Dental
Date received: 2006-12-13
Decision date: 2007-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carol Stream, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EEG

view all

K122725 — TANDA PEARL, ULTRAWYTE, PEARL2012-11-27
K110888 — ABSOLUTE WHITE LIGHT2012-01-12
K052040 — QUICKSMILE2005-10-18
K041392 — SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US2004-11-08
K042153 — SOUTH BEACH SMILE LIGHT WHITENING SYSTEM2004-11-08

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