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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 -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 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
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