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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Crown And Bridge, Temporary, Resin
510(k) Number K080556
Device Name ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES
Applicant
Merz Dental GmbH
5616 Mariola Pl. NE
Albuquerque,  NM  87111
Applicant Contact RICHARD G HUNTER, M.S., RAC
Correspondent
Merz Dental GmbH
5616 Mariola Pl. NE
Albuquerque,  NM  87111
Correspondent Contact RICHARD G HUNTER, M.S., RAC
Regulation Number872.3770
Classification Product Code
EBG  
Date Received02/28/2008
Decision Date 05/02/2008
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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