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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 K160615
Device Name ORTHODONTIC CERAMIC BRACKETS 1.1
Applicant
Tomy, Inc.
6 Tenko Blg. 3-16-7
Midoricho, Fuchu City,  JP 183-0006
Applicant Contact JINICHI WATANABE
Correspondent
Primus Consulting
7046 Owls Nest Terr
Bradenton,  FL  34203
Correspondent Contact CAROLYN PRIMUS
Regulation Number872.5470
Classification Product Code
NJM  
Date Received03/03/2016
Decision Date 08/26/2016
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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