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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Powered Radiofrequency Toothbrush
510(k) Number K214078
Device Name Silk’n Toothwave
Applicant
Home Skinovations , Ltd.
Tabor Bldg., Shaar Yokneam
Yokneam,  IL 2069200
Applicant Contact Amit Goren
Correspondent
A. Stein Regulatory Affairs Consulting , Ltd.
18 Hata'As St.
Suite 21
Kfar Saba,  IL 4442518
Correspondent Contact Amit Goren
Regulation Number872.6866
Classification Product Code
QMJ  
Date Received12/27/2021
Decision Date 01/13/2023
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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