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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Liner, Cavity, Calcium Hydroxide
510(k) Number K253248
Device Name Bright Cavity Liner
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 Number872.3250
Classification Product Code
EJK  
Date Received09/29/2025
Decision Date 01/13/2026
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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