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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 K231338
Device Name 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment
Applicant
3M ESPE Dental Products
2510 Conway Avenue
Saint Paul,  MN  55144
Applicant Contact Chandrapaul Parsram
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.3260
Classification Product Code
LBH  
Date Received05/08/2023
Decision Date 05/10/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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