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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name heat source for bleaching teeth
510(k) Number K122725
Device Name TANDA PEARL, ULTRAWYTE, PEARL
Original Applicant
SYNERON BEAUTY
1835 market st., 29th floor
philadelphia,  PA  19103
Original Contact janice m hogan
Regulation Number872.6475
Classification Product Code
EEG  
Date Received09/05/2012
Decision Date 11/27/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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