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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 K160867
Device Name Pavati Z40.2 Zirconia
Applicant
Ccri, Inc.
1319 Calle Avanzado
San Clemente,  CA  92673
Applicant Contact ROBIN CARDEN
Correspondent
Ccri, Inc.
1319 Calle Avanzado
San Clemente,  CA  92673
Correspondent Contact ROBIN CARDEN
Regulation Number872.6660
Classification Product Code
EIH  
Date Received03/30/2016
Decision Date 09/12/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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