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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
Applicant
IVOCLAR VIVADENT AG
175 PINEVIEW DR.
AMHERST,  NY  14228
Applicant Contact DONNA M HARTNETT
Correspondent
IVOCLAR VIVADENT AG
175 PINEVIEW DR.
AMHERST,  NY  14228
Correspondent Contact DONNA M HARTNETT
Regulation Number872.3590
Classification Product Code
ELM  
Date Received03/09/2012
Decision Date 05/14/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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