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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Ceramic, Orthodontic
510(k) Number K123092
Device Name CERAMIN BRACKETS Z
Applicant
Tomy, Inc.
7046 Owl'S Nest Ter.
Bradenton,  FL  34203
Applicant Contact CAROLYN PRIMUS
Correspondent
Tomy, Inc.
7046 Owl'S Nest Ter.
Bradenton,  FL  34203
Correspondent Contact CAROLYN PRIMUS
Regulation Number872.5470
Classification Product Code
NJM  
Date Received10/02/2012
Decision Date 12/21/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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