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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
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