ABSOLUTE WHITE LIGHT


Device Classification Name

heat source for bleaching teeth

510(k) Number K110888
Device Name ABSOLUTE WHITE LIGHT
Applicant
DR. FRESH, INC.
12101 cullen blvd
houston, 
TX 
77047 -1131

Applicant Contact m. joyce heinrich
Correspondent
DR. FRESH, INC.
12101 cullen blvd
houston, 
TX 
77047 -1131

Correspodent Contact m. joyce heinrich
Regulation Number 872.6475
Classification Product Code
EEG  
Date Received 03/30/2011
Decision Date 01/12/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Dental

510k Review Panel

Dental

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No