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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 K252469
Device Name MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA
Applicant
Dmp Dental Industry S.A.
Kalyvion Ave.
Markopoulo,  GR 19003
Applicant Contact Konstantinos Kyritsis
Correspondent
Dmp Dental Industry S.A.
Kalyvion Ave.
Markopoulo,  GR 19003
Correspondent Contact Konstantinos Kyritsis
Regulation Number872.3200
Classification Product Code
KLE  
Date Received08/06/2025
Decision Date 11/06/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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