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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Diammine Silver Fluoride Dental Hypersensitivity Varnish
510(k) Number K240619
Device Name e-SDF
Applicant
Kids-E-Dental Llp
411- Akruti Arcade Jp Rd., Azad Nagar, Opp A.H. Wadia
School, Andheri W.
Mumbai,  IN 400053
Applicant Contact Mukul Jain
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.3260
Classification Product Code
PHR  
Date Received03/05/2024
Decision Date 03/06/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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