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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 K211010
Device Name Illusion Aligners
Laxmi Dental Exports Pvt Ltd
Survey No. 201/1, Village Gundale, Boisar Chillar Highway
Boisar,  IN 401501
Applicant Contact Sameer Merchant
Accelerated Device Approval Services
6800 S.W. 40th Street, Ste. 403
Ludlum,  FL  33155
Correspondent Contact Rafael Aguila
Regulation Number872.5470
Classification Product Code
Date Received04/05/2021
Decision Date 04/26/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No