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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 K851053
Device Name TUBULITEC LINER
Applicant
Dental Therapeutics AB
Ektorpsvacen 3 S-13145
Nacka,  SE
Applicant Contact BERNDT LAGERSTEDT
Correspondent
Dental Therapeutics AB
Ektorpsvacen 3 S-13145
Nacka,  SE
Correspondent Contact BERNDT LAGERSTEDT
Regulation Number872.3250
Classification Product Code
EJK  
Date Received03/14/1985
Decision Date 07/25/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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