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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 K934827
Device Name BRANEMARK SYSTEM ESTHETICONE NON-ROTATIONAL SYSTEM
Applicant
Nobelpharma USA, Inc.
5101 S. Keeler Ave.
Chicago,  IL  60632
Applicant Contact ALAN I BECKER
Correspondent
Nobelpharma USA, Inc.
5101 S. Keeler Ave.
Chicago,  IL  60632
Correspondent Contact ALAN I BECKER
Regulation Number872.3640
Classification Product Code
DZE  
Date Received10/08/1993
Decision Date 08/08/1994
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
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