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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Toothbrush, Powered
510(k) Number K891694
Device Name THE SMILE MACHINE
Applicant
Brilliant Industries, Inc.
137 Montgomery Ave.
Bala Cynwyd,  PA  19004
Applicant Contact HERBERT BRILLIANT
Correspondent
Brilliant Industries, Inc.
137 Montgomery Ave.
Bala Cynwyd,  PA  19004
Correspondent Contact HERBERT BRILLIANT
Regulation Number872.6865
Classification Product Code
JEQ  
Date Received03/22/1989
Decision Date 06/16/1989
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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