510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Tokuyama Dental Corporation

Washington, DC, US

Tokuyama Dental Corporation appears in FDA device records in Washington, DC. FDA records list 19 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
19
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 19 510(k) clearances for Tokuyama Dental Corporation between 2003 and 2021. The busiest year on record is 2017, with 3. The most recent is 2021, with 2.

Clearances by year, as a table
510(k) clearance decisions for Tokuyama Dental Corporation, by decision year
YearClearances
20031
20051
20072
20081
20091
20101
20112
20151
20173
20182
20191
20201
20212
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K203760Tokuyama Universal Bond IIKLESubstantially Equivalent
K203598Omnichroma Flow BulkEBFSubstantially Equivalent
K193537Omnichroma FlowEBFSubstantially Equivalent
K190940Tokuyama Rebase IIIEBISubstantially Equivalent
K180613Estelite Universal FlowEBFSubstantially Equivalent
K173275OMNICHROMAEBFSubstantially Equivalent
K171226TOKUYAMA UNIVERSAL BONDKLESubstantially Equivalent
K170549TOKUYAMA CUREGRACEEBISubstantially Equivalent
K161353ESTELITE BULK FILL FlowEBFSubstantially Equivalent
K150727ESTECEMEMASubstantially Equivalent
K112445SOFRELINER TOUGH SEBISubstantially Equivalent
K110178ESTELITE COLOREBFSubstantially Equivalent
K100172TOKUYAMA SHIELD FORCELBHSubstantially Equivalent
K081554TOKUYAMA TISSUECAREEBISubstantially Equivalent
K080940ESTELITE SIGMA QUICKEBFSubstantially Equivalent
K072746E-1 ESTHETIC COMPOSITE SYSTEMEBFSubstantially Equivalent
K070215TOKUYAMA BOND FORCEKLESubstantially Equivalent
K051808ESTELITE FLOW QUICKEBFSubstantially Equivalent
K030663TOKUYAMA SOFRELINER TOUGHEBISubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain