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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 K222323
Device Name Black Diamond
Applicant
Elevate Oral Care, LLC
346 Pike Rd.
Suite 5
West Palm Beach,  FL  33411
Applicant Contact Steve Pardue
Correspondent
Elevate Oral Care
346 Pike Rd.
Suite 5
West Palm Beach,  FL  33411
Correspondent Contact Steve Pardue
Regulation Number872.3260
Classification Product Code
PHR  
Date Received08/02/2022
Decision Date 06/23/2023
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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