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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 K171844
Device Name Inspire ICE aka Inspire ICE Clear Brackets
Applicant
Ormco Corporation
1717 W. Collins Avenue
Orange,  CA  92867
Applicant Contact Tara Bonny
Correspondent
THIRD PARTY REVIEW GROUP, LLC
25 Independence Blvd
Warren,  NJ  07059
Correspondent Contact DAVE YUNGVIRT
Regulation Number872.5470
Classification Product Code
NJM  
Subsequent Product Code
EJF  
Date Received06/20/2017
Decision Date 07/18/2017
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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