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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 Rd.
Sound Beach,  NY  11764
Applicant Contact STEPHEN T MLCOCH
Correspondent
Wright Health Group , Ltd.
30 Northport Rd.
Sound Beach,  NY  11764
Correspondent Contact STEPHEN T MLCOCH
Regulation Number872.3590
Classification Product Code
ELM  
Date Received09/25/2012
Decision Date 03/01/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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