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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 K233768
Device Name Papacarie Duo
Applicant
Elevate Oral Care
346 Pike Rd
Suite 5
West Palm Beach,  FL  33411
Applicant Contact Steven Pardue
Correspondent
Elevate Oral Care
346 Pike Rd
Suite 5
West Palm Beach,  FL  33411
Correspondent Contact Steven Pardue
Regulation Number872.3260
Classification Product Code
LBH  
Subsequent Product Code
KLE  
Date Received11/24/2023
Decision Date 07/18/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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