FDA 510(k) Applications for Medical Device Product Code "EEG"
(Heat Source For Bleaching Teeth)

FDA 510(k) Number Applicant Device Name Decision Date
K063704 BEKS INCORPORATED BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101 02/20/2007
K041392 CAO GROUP, INC. SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US 11/08/2004
K052040 COSMETIC DENTAL MATERIALS INC QUICKSMILE 10/18/2005
K042153 DENTOVATIONS, INC. SOUTH BEACH SMILE LIGHT WHITENING SYSTEM 11/08/2004
K110888 DR. FRESH, INC. ABSOLUTE WHITE LIGHT 01/12/2012
K122725 SYNERON BEAUTY TANDA PEARL, ULTRAWYTE, PEARL 11/27/2012


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