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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Varnish, Cavity
510(k) Number K242913
Device Name Jasmate® Toothpaste
Applicant
Jasberry Healthcare Private Limited
162 Model Town
Kapurthala,  IN 144401
Applicant Contact Balwant Rai
Correspondent
Jasberry Healthcare Private Limited
162 Model Town
Kapurthala,  IN 144401
Correspondent Contact Balwant Rai
Regulation Number872.3260
Classification Product Code
LBH  
Date Received09/24/2024
Decision Date 11/22/2024
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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