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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Agent, Tooth Bonding, Resin
510(k) Number K251587
Device Name VITA VMLC Primer
Applicant
Vita Zahnfabrik H. Rauter GmbH & Co. Kg.
Spitalgasse 3
Bad Sackingen
Baden-Wurttemberg,  DE D-79713
Applicant Contact Lindsay Tilton
Correspondent
Vita Zahnfabrik H. Rauter GmbH & Co. Kg.
Spitalgasse 3
Bad Sackingen
Baden-Wurttemberg,  DE D-79713
Correspondent Contact Lindsay Tilton
Regulation Number872.3200
Classification Product Code
KLE  
Date Received05/23/2025
Decision Date 02/23/2026
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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