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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Alloy, Metal, Base
510(k) Number K001269
Device Name DENTALMATIC TI PROSTHESIS AND DENTALMATIC TI-A PROSTHETIC
Applicant
DENTALMATIC TECHNOLOGIES, INC.
9710 TRANSCANADA HIGHWAY ST
ST LAURENT, QC,  CA H4S 1V9
Applicant Contact NAOUM ARAJ
Correspondent
DENTALMATIC TECHNOLOGIES, INC.
9710 TRANSCANADA HIGHWAY ST
ST LAURENT, QC,  CA H4S 1V9
Correspondent Contact NAOUM ARAJ
Regulation Number872.3710
Classification Product Code
EJH  
Date Received04/20/2000
Decision Date 06/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
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