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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 K122925
Device Name NEW STETIC ARTIFICIAL TEETH
Applicant
New Stetic
445 Apollo Beach Blvd.
Apollo Beach,  FL  33572
Applicant Contact JOHN OBRIEN
Correspondent
New Stetic
445 Apollo Beach Blvd.
Apollo Beach,  FL  33572
Correspondent Contact JOHN OBRIEN
Regulation Number872.3590
Classification Product Code
ELM  
Date Received09/24/2012
Decision Date 02/12/2013
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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