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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
FOIA Releasable 510(k) K211010
Device Name Illusion Aligners
Applicant
Laxmi Dental Exports Pvt, Ltd.
Survey # 201/1, Village Gundale, Boisar Chillar Hwy.
Boisar,  IN 401501
Applicant Contact Sameer Merchant
Correspondent
Accelerated Device Approval Services
6800 SW 40th St., Suite 403
Ludlum,  FL  33155
Correspondent Contact Rafael Aguila
Regulation Number872.5470
Classification Product Code
NXC  
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
Predetermined Change
Control Plan Authorized		 No
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