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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name denture, plastic, teeth
510(k) Number K120404
Device Name MERZ DENTAL GMBH ARTEGRAL HD PREFORMED PLASTIC DENTURE TEETH
Original Applicant
MERZ DENTAL GMBH
5616 mariola pl ne
albuquerque,  NM  87111
Original Contact richard g hunter
Regulation Number872.3590
Classification Product Code
ELM  
Date Received02/09/2012
Decision Date 05/21/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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