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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aligner, Sequential
510(k) Number K182329
Device Name SureCure Orthodontic Aligner System
Applicant
Digital Orthodontic Care
348 Bronte Street, Unit 16
Milton,  CA L925B6
Applicant Contact Jeff Sheppard
Correspondent
Trisler Consulting
5600 Wisconsin Avenue, #509
Chevy Chase,  MD  20815
Correspondent Contact Patsy J. Trisler
Regulation Number872.5470
Classification Product Code
NXC  
Date Received08/28/2018
Decision Date 11/08/2018
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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