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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 K955697
Device Name ABUTMENT RETRIEVAL KIT
Applicant
Nobelpharma USA, Inc.
777 Oakmont Ln.
Suite 100
Westmont,  IL  60559
Applicant Contact MARY EDWARDS
Correspondent
Nobelpharma USA, Inc.
777 Oakmont Ln.
Suite 100
Westmont,  IL  60559
Correspondent Contact MARY EDWARDS
Regulation Number872.3640
Classification Product Code
DZE  
Date Received12/14/1995
Decision Date 01/30/1996
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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