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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 K222918
Device Name DentCare Aligners
Applicant
DentCare Dental Lab Pvt Ltd.
NAS Road, 130 Jn. Muvattupuzha
Ernakulam,  IN 686661
Applicant Contact Abin Johns Raju
Correspondent
Liberty Management Group Ltd.
75 Executive Drive,
Suite 114
Aurora,  IL  60504
Correspondent Contact Manoj Zacharias
Regulation Number872.5470
Classification Product Code
NXC  
Date Received09/26/2022
Decision Date 11/25/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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