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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 west collins avenue
orange,  CA  92867
Contact wendy garman
Regulation Number872.3661
Classification Product Code
NOF  
Date Received07/13/2012
Decision Date 02/08/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
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