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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 K223338
Device Name Toothsi, Smilealigners
Applicant
Makeo Healthcare Technologies Private Limited
902, 9th Floor, B Wing,Raheja Plz. Lal Bahadur Shastri Marg
Nityanand Nagar Ghatkopar W.
Mumbai,  IN 400086
Applicant Contact Manjul Jain
Correspondent
Intrust
A301/A Green Heritage, Plot 79-80, Sector 20
Kharghar,  IN 410210
Correspondent Contact Sanjeev Kumar Gupta
Regulation Number872.5470
Classification Product Code
NXC  
Date Received11/01/2022
Decision Date 02/09/2023
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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