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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 K120873
Device Name ZIMMER ZFX ABUTMENT FOR NOBEL REPLACE IMPLANT SYSTEM
Applicant
ZIMMER DENTAL INC.
1900 ASTON AVE.
CARLSBAD,  CA  92008 -7308
Applicant Contact MELISSA BURBAGE
Correspondent
ZIMMER DENTAL INC.
1900 ASTON AVE.
CARLSBAD,  CA  92008 -7308
Correspondent Contact MELISSA BURBAGE
Regulation Number872.3630
Classification Product Code
NHA  
Date Received03/22/2012
Decision Date 11/08/2012
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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