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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name cement, dental
510(k) Number K120432
Device Name TELIO CS CEM IMPLANT
Original Applicant
IVOCLAR VIVADENT AG
175 pineview dr.
amherst,  NY  14228
Original Contact donna marie hartnett
Regulation Number872.3275
Classification Product Code
EMA  
Date Received02/13/2012
Decision Date 06/08/2012
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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