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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 K212961
Device Name SMILERS
Applicant
Biotech Dental Smilers, Sas
305, Allée De Craponne
Salon De Provence,  FR 13300
Applicant Contact Delphine Mercier
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.5470
Classification Product Code
NXC  
Date Received09/16/2021
Decision Date 09/20/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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