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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
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