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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 K141611
Device Name LYTHOS DIGITAL IMPRESSION SYSTEM
Applicant
ORMCO CORP.
1717 WEST COLLINS AVENUE
ORANGE,  CA  92867
Applicant Contact COURTNEY CLARK
Correspondent
ORMCO CORP.
1717 WEST COLLINS AVENUE
ORANGE,  CA  92867
Correspondent Contact COURTNEY CLARK
Regulation Number872.3661
Classification Product Code
NOF  
Date Received06/16/2014
Decision Date 12/05/2014
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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