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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 K092403
Device Name TI PREPABLE ABUTMENT, MODEL 1618, 1619, 1620
Applicant
Zimmer Dental, Inc.
1900 Aston Ave.
Carlsbad,  CA  92008
Applicant Contact LARISSA D ANDREA MCMULLIN
Correspondent
Zimmer Dental, Inc.
1900 Aston Ave.
Carlsbad,  CA  92008
Correspondent Contact LARISSA D ANDREA MCMULLIN
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/06/2009
Decision Date 10/30/2009
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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