Dental Device Guide
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Not currently registered with FDA under this name

Tokuyama America, Inc.

Washington, DC, United States. Named as applicant on 22 dental 510(k) clearances between 1990 and 2002. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
221990–2002
Markets registered in
1United States
Establishments
0—
1990: 51991: 41996: 11997: 11998: 41999: 12000: 12001: 42002: 11990200020102020

510(k) clearances per year, 1990–2026

510(k) clearances

Clearances on which FDA names Tokuyama America, Inc. as the applicant.

Decided510(k)DeviceDevice type
2 Oct 2002K022641TOKUYAMA REBASE IIEBI Rebasing Repairing Relining Denture Resin
4 Sep 2001K011854TOKUYAMA M-BONDEMA Dental Cement
31 Jul 2001K011685BISTITE II DCEMA Dental Cement
27 Feb 2001K010267PALFIQUE ESTELITE LV CLEAREBF Resin Tooth Shade Material
4 Jan 2001K002863PALFIQUE ESTELITE LVEBF Resin Tooth Shade Material
2 Feb 2000K993917TOKUYAMA ONE-UP-BOND FKLE Resin Tooth Bonding Agent
7 Jul 1999K991711BISTITE II SCEMA Dental Cement
24 Aug 1998K982537TOKUYAMA SOFRELINEREBI Rebasing Repairing Relining Denture Resin
27 Apr 1998K980058TOKUSO MAC BOND IIEBF Resin Tooth Shade Material
27 Apr 1998K980054PALFIQUE ESTELITEEBF Resin Tooth Shade Material
24 Feb 1998K980051PALFIQUE ESTELITE PASTEEBF Resin Tooth Shade Material
7 Oct 1997K973245TOKUSO REBASE MR. BONDKLE Resin Tooth Bonding Agent
18 Jan 1996K953589TOKUYAMA SOFT RELININGEBI Rebasing Repairing Relining Denture Resin
2 Oct 1991K913100PALFIQUE INLAYEBF Resin Tooth Shade Material
2 Oct 1991K913099PALFIQUE LITEPOSTERIOREBF Resin Tooth Shade Material
29 May 1991K911524PALFIQUE ESTELITEEBF Resin Tooth Shade Material
15 May 1991K911525TOKUSO LIGHT BONDKLE Resin Tooth Bonding Agent
15 May 1990K897011PALFIQUE LIGHT-S COMPOSITE RESINEBF Resin Tooth Shade Material
15 May 1990K897010PALFIQUE LIGHT COMPOSITE RESINEBF Resin Tooth Shade Material
15 May 1990K897009PALFIQUE LIGHT BONDING AGENTKLE Resin Tooth Bonding Agent
15 May 1990K896981TOKUSO REBASEEBI Rebasing Repairing Relining Denture Resin
15 May 1990K896980PALFIQUE LIGHT LINEREBI Rebasing Repairing Relining Denture Resin

Some of these clearances are listed with FDA today by another company: Tokuyama Dental Corporation (2).

Sources

FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.