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Tokuyama Dental Corporation

FDA Regulatory Profile

Tokuyama Dental Corporation has 0 FDA recalls, 1 inspection, 19 510(k) clearances and 0 compliance actions on record.

Latest inspection
Sep 3, 2013 · NAI
Latest 510(k)
May 25, 2021

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances19Oct 4, 2026Not statedCurrent
Inspections1Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Sep 3, 2013Kamisu, JapanDevicesNo Action Indicated (NAI)3003621174

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K203760Tokuyama Universal Bond IIMay 25, 2021
K203598Omnichroma Flow BulkFeb 3, 2021
K193537Omnichroma FlowAug 19, 2020
K190940Tokuyama Rebase IIIOct 4, 2019
K180613Estelite Universal FlowJul 12, 2018
K173275OMNICHROMAFeb 27, 2018
K171226TOKUYAMA UNIVERSAL BONDNov 28, 2017
K170549TOKUYAMA CUREGRACEJul 5, 2017
K161353ESTELITE BULK FILL FlowApr 3, 2017
K150727ESTECEMJun 17, 2015
K112445SOFRELINER TOUGH SOct 28, 2011
K110178ESTELITE COLORApr 5, 2011
K100172TOKUYAMA SHIELD FORCEOct 21, 2010
K081554TOKUYAMA TISSUECAREMar 18, 2009
K080940ESTELITE SIGMA QUICKJun 19, 2008
K072746E-1 ESTHETIC COMPOSITE SYSTEMDec 4, 2007
K070215TOKUYAMA BOND FORCEMar 30, 2007
K051808ESTELITE FLOW QUICKAug 8, 2005
K030663TOKUYAMA SOFRELINER TOUGHMay 29, 2003

FDA data resources