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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 K925762
Device Name BRANEMARK SYSTEM SELF-TAPPING FIXTURE
Applicant
NOBELPHARMA USA, INC.
333 WEST WACKER DR.
SUITE 2600
CHICAGO,  IL  60606
Applicant Contact THOMAS L PARKER
Correspondent
NOBELPHARMA USA, INC.
333 WEST WACKER DR.
SUITE 2600
CHICAGO,  IL  60606
Correspondent Contact THOMAS L PARKER
Regulation Number872.3640
Classification Product Code
DZE  
Date Received11/13/1992
Decision Date 10/12/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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