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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 K173785
Device Name Custom Clear Aligner System
Applicant
Derby Dental Laboratory
3332 Gilmore Industrial Blvd
Louisville,  KY  40213
Applicant Contact Reed Nunnally
Correspondent
Trisler Consulting
5600 Wisconsin Ave, #509
Chevy Chase,  MD  20815
Correspondent Contact Patsy J Trisler
Regulation Number872.5470
Classification Product Code
NXC  
Date Received12/13/2017
Decision Date 03/13/2018
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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