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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name denture, plastic, teeth
510(k) Number K120736
Device Name SR PHONARES II
Original Applicant
IVOCLAR VIVADENT AG
175 pineview dr.
amherst,  NY  14228
Original Contact donna m hartnett
Regulation Number872.3590
Classification Product Code
ELM  
Date Received03/19/2012
Decision Date 05/14/2012
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
statement statement
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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