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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 K222619
Device Name Ensmile
Applicant
Ensmile Pvt Ltd
Main Canal RD, No. 2 Block H
Johar Town,  PK 54000
Applicant Contact Mirza Gohar Rehman
Correspondent
Ensmile Pvt Ltd
Main Canal RD, No. 2 Block H
Johar Town,  PK 54000
Correspondent Contact Mirza Gohar Rehman
Regulation Number872.5470
Classification Product Code
NXC  
Date Received08/30/2022
Decision Date 03/16/2023
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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