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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 K062749
Device Name SBF 15 ESTHETIC ABUTMENT 1MM NP, MODEL 33699, SFB 15 ESTHETIC ABUTMENT 1MM RP, MODEL 33701, CFB 15 ESTHETIC ABUTMENT 2MM
Applicant
NOBEL BIOCARE AB
15 BOHUSGATAN,
P.O. BOX 5190
GOTEBORG,  SE S-402 26
Applicant Contact HERBERT CRANE
Correspondent
NOBEL BIOCARE AB
15 BOHUSGATAN,
P.O. BOX 5190
GOTEBORG,  SE S-402 26
Correspondent Contact HERBERT CRANE
Regulation Number872.3630
Classification Product Code
NHA  
Date Received09/14/2006
Decision Date 11/29/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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