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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Bracket, Plastic, Orthodontic
510(k) Number K180718
Device Name ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES
Applicant
Tomy, Inc.
Tenko Bldg. 3-16-7
Midori-Cho, Fuchu City,  JP 183-0006
Applicant Contact Jinichi Watanabe
Correspondent
Regulatory & Quality Solutions, Inc.
2790 Mosside Blvd.
#800
Monroeville,  PA  15146
Correspondent Contact Ruthanne Vendy
Regulation Number872.5470
Classification Product Code
DYW  
Date Received03/19/2018
Decision Date 10/30/2018
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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