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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Over The Counter Electrical Salivary Stimulatory System
510(k) Number K220618
Device Name SaliPen
Applicant
Saliwell , Ltd.
3a Hatamar St.
Harutzim,  IL 6091700
Applicant Contact Ben Beiski
Correspondent
Saliwell , Ltd.
3a Hatamar St.
Harutzim,  IL 6091700
Correspondent Contact Andy Z. Wolff
Regulation Number872.5560
Classification Product Code
QTT  
Date Received03/03/2022
Decision Date 08/30/2022
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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