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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Material, Tooth Shade, Resin
510(k) Number K173275
Device Name OMNICHROMA
Applicant
Tokuyama Dental Corporation
38-9 Taitou 1-Chome, Taitou-Ku
Tokyo,  JP 110-0016
Applicant Contact Keith A. Barritt
Correspondent
Fish & Richardson, P.C.
901 15th St., Suite 700
Washington,  DC  20005
Correspondent Contact Keith A. Barritt
Regulation Number872.3690
Classification Product Code
EBF  
Date Received10/12/2017
Decision Date 02/27/2018
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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