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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name powder, porcelain
510(k) Number K121359
Device Name IPS 99 ONE AND IPS 99 CERAM
Original Applicant
175 pineview dr.
amherst,  NY  14228
Original Contact donna marie hartnett
Regulation Number872.6660
Classification Product Code
Date Received05/07/2012
Decision Date 07/27/2012
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