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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 K010073
Device Name SPLINE DENTAL IMPLANT SYSTEM
Applicant
Sulzer Calcitek, Inc.
1900 Aston Ave.
Carlsbad,  CA  92008 -7308
Applicant Contact FOSTER BOOP
Correspondent
Sulzer Calcitek, Inc.
1900 Aston Ave.
Carlsbad,  CA  92008 -7308
Correspondent Contact FOSTER BOOP
Regulation Number872.3640
Classification Product Code
DZE  
Date Received01/09/2001
Decision Date 01/19/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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