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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 K243777
Device Name Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)
Applicant
Theodent, LLC
1441 Canal St.
New Orleans,  LA  70112
Applicant Contact Joseph Fuselier
Correspondent
Blackwell Device Consulting
1441 Canal St.
New Orleans,  LA  70112
Correspondent Contact Andrew Fuselier
Regulation Number872.3260
Classification Product Code
LBH  
Date Received12/09/2024
Decision Date 05/27/2025
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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