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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name system, optical impression, computer assisted design and manufacturing (cad/cam) of dental restorations
510(k) Number K122467
Device Name 3M TRUE DEFINITION SCANNER
Applicant
3M COMPANY
2510 CONWAY AVENUE
ST. PAUL,  MN  55144
Applicant Contact GINGER CANTOR
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number872.3661
Classification Product Code
NOF  
Date Received08/13/2012
Decision Date 11/20/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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