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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 W. Wacker Dr.
Suite 2600
Chicago,  IL  60606
Applicant Contact THOMAS L PARKER
Correspondent
Nobelpharma USA, Inc.
333 W. 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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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