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

Torrance, CA, US

TOKUYAMA AMERICA INC. appears in FDA device records in Torrance, CA. FDA records list 22 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
22
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 22 510(k) clearances for Tokuyama America Inc. between 1990 and 2002. The busiest year on record is 1990, with 5. The most recent is 2002, with 1.

Clearances by year, as a table
510(k) clearance decisions for Tokuyama America Inc., by decision year
YearClearances
19905
19914
19961
19971
19984
19991
20001
20014
20021
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K022641TOKUYAMA REBASE IIEBISubstantially Equivalent
K011854TOKUYAMA M-BONDEMASubstantially Equivalent
K011685BISTITE II DCEMASubstantially Equivalent
K010267PALFIQUE ESTELITE LV CLEAREBFSubstantially Equivalent
K002863PALFIQUE ESTELITE LVEBFSubstantially Equivalent
K993917TOKUYAMA ONE-UP-BOND FKLESubstantially Equivalent
K991711BISTITE II SCEMASubstantially Equivalent
K982537TOKUYAMA SOFRELINEREBISubstantially Equivalent
K980058TOKUSO MAC BOND IIEBFSubstantially Equivalent
K980054PALFIQUE ESTELITEEBFSubstantially Equivalent
K980051PALFIQUE ESTELITE PASTEEBFSubstantially Equivalent
K973245TOKUSO REBASE MR. BONDKLESubstantially Equivalent
K953589TOKUYAMA SOFT RELININGEBISubstantially Equivalent
K913100PALFIQUE INLAYEBFSubstantially Equivalent
K913099PALFIQUE LITEPOSTERIOREBFSubstantially Equivalent
K911524PALFIQUE ESTELITEEBFSubstantially Equivalent
K911525TOKUSO LIGHT BONDKLESubstantially Equivalent
K897011PALFIQUE LIGHT-S COMPOSITE RESINEBFSubstantially Equivalent
K897010PALFIQUE LIGHT COMPOSITE RESINEBFSubstantially Equivalent
K897009PALFIQUE LIGHT BONDING AGENTKLESubstantially Equivalent
K896981TOKUSO REBASEEBISubstantially Equivalent
K896980PALFIQUE LIGHT LINEREBISubstantially Equivalent

Registered establishments

FDA registered establishments for Tokuyama America Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30478945603047894560TOKUYAMA AMERICA INC.3655 Torrance Blvd Fl 3, Torrance, CA 90503 US2026No device listings on this registration

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

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

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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