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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 K092377
Device Name PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S
Applicant
Zimmer Dental, Inc.
1900 Aston Ave.
Carlsbad,  CA  92008 -7308
Applicant Contact WILLIAM FISHER
Correspondent
Zimmer Dental, Inc.
1900 Aston Ave.
Carlsbad,  CA  92008 -7308
Correspondent Contact WILLIAM FISHER
Regulation Number872.3630
Classification Product Code
NHA  
Date Received08/05/2009
Decision Date 11/03/2009
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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