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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Anchor, Preformed
510(k) Number K133088
Device Name ZX-27
Applicant
M&M Dental Studio, Inc.
420 Lexington Ave.
Suite 2400
New York,  NY  10170
Applicant Contact IRVING WIESEN
Correspondent
M&M Dental Studio, Inc.
420 Lexington Ave.
Suite 2400
New York,  NY  10170
Correspondent Contact IRVING WIESEN
Regulation Number872.3130
Classification Product Code
EJX  
Date Received09/30/2013
Decision Date 01/02/2015
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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