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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Post, Root Canal
510(k) Number K870130
Device Name DEN-MAT SECURE ANTI-ROTATIONAL POST-CORE SYSTEM
Applicant
Den-Mat Corp.
P.O. Box 1729
Santa Maria,  CA  93456
Applicant Contact ROBERT L IBSEN
Correspondent
Den-Mat Corp.
P.O. Box 1729
Santa Maria,  CA  93456
Correspondent Contact ROBERT L IBSEN
Regulation Number872.3810
Classification Product Code
ELR  
Date Received01/12/1987
Decision Date 02/19/1987
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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