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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name abutment, implant, dental, endosseous
510(k) Number K925779
Device Name BRANEMARK SYSTEM TITANIUM HEALING ABUTMENTS
Applicant
NOBELPHARMA USA, INC.
333 WEST WACKER DR.
SUITE 2600
CHICAGO,  IL  60606
Applicant Contact THOMAS J MULDOON
Correspondent
NOBELPHARMA USA, INC.
333 WEST WACKER DR.
SUITE 2600
CHICAGO,  IL  60606
Correspondent Contact THOMAS J MULDOON
Regulation Number872.3630
Classification Product Code
NHA  
Date Received11/16/1992
Decision Date 04/20/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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