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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Endosseous, Root-Form
510(k) Number K082639
Device Name ZIMMER DENTAL TAPERED SWISSPLUS IMPLANTS
Applicant
Zimmer Dental, Inc.
1900 Aston Ave.
Carlsbad,  CA  92008
Applicant Contact WILLIAM FISHER
Correspondent
Zimmer Dental, Inc.
1900 Aston Ave.
Carlsbad,  CA  92008
Correspondent Contact WILLIAM FISHER
Regulation Number872.3640
Classification Product Code
DZE  
Date Received09/10/2008
Decision Date 12/19/2008
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
Recalls CDRH Recalls
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