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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 ROAD
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
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