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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 K001786
Device Name TEMPORARY GINGIVAL CUFF AND IMPRESSION POST AND IMPLANT ANALOG
Applicant
Sulzer Calcitek, Inc.
1900 Aston Ave.
Carlsbad,  CA  92008
Applicant Contact FOSTER BOOP
Correspondent
Sulzer Calcitek, Inc.
1900 Aston Ave.
Carlsbad,  CA  92008
Correspondent Contact FOSTER BOOP
Regulation Number872.3640
Classification Product Code
DZE  
Date Received06/13/2000
Decision Date 06/21/2000
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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