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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name bracket, ceramic, orthodontic
510(k) Number K172845
Device Name Symetri Clear
Applicant
Ormco Corporation
1717 W. Collins Avenue
Orange,  CA  92867
Applicant Contact Tara Bonny
Correspondent
Ormco Corporation
1717 W. Collins Avenue
Orange,  CA  92867
Correspondent Contact Tara Bonny
Regulation Number872.5470
Classification Product Code
NJM  
Date Received09/19/2017
Decision Date 01/31/2018
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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