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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K123220
Device Name VERTEX THERMOSENS RIGID
Applicant
Vertex-Dental B.V.
154 Main St.
Charlestown,  NH  03603
Applicant Contact MASON DIAMOND
Correspondent
Vertex-Dental B.V.
154 Main St.
Charlestown,  NH  03603
Correspondent Contact MASON DIAMOND
Regulation Number872.3760
Classification Product Code
EBI  
Date Received10/15/2012
Decision Date 03/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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