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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 K122065
Device Name DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE
Applicant
Ormco Corp.
1717 W. Collins Ave.
Orange,  CA  92867
Applicant Contact Wendy Garman
Correspondent
Ormco Corp.
1717 W. Collins Ave.
Orange,  CA  92867
Correspondent Contact Wendy Garman
Regulation Number872.3661
Classification Product Code
NOF  
Date Received07/13/2012
Decision Date 02/08/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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