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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K113092
Device Name ZIMMER CONTOUR PROVISIONAL COPING
Applicant
ZIMMER DENTAL INC.
1900 ASTON AVE.
CARLSBAD,  CA  92008 -7308
Applicant Contact JEREMY MARKOVICH
Correspondent
ZIMMER DENTAL INC.
1900 ASTON AVE.
CARLSBAD,  CA  92008 -7308
Correspondent Contact JEREMY MARKOVICH
Regulation Number872.3630
Classification Product Code
NHA  
Date Received10/19/2011
Decision Date 01/23/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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