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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 K122955
Device Name DENTAVIT, MONARCH, ACROTONE, SENATOR, DENTORIUM
Applicant
WRIGHT HEALTH GROUP LTD.
30 northport road
sound beach,  NY  11764
Contact stephen t mlcoch
Regulation Number872.3590
Classification Product Code
ELM  
Date Received09/25/2012
Decision Date 03/01/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Dental
Review Advisory Committee Dental
summary summary
Type Abbreviated
Reviewed by Third Party No
Expedited Review No
Combination Product No
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