Medical Device Manufacturer · US , Washington , DC

Tokuyama America, Inc. - FDA 510(k) Cleared Devices

22 submissions · 22 cleared · Since 1990

22

Total

22

Cleared

0

Denied

FDA 510(k) Regulatory Record - Tokuyama America, Inc. Dental ✕

22 devices

1-22 of 22

Cleared Oct 02, 2002

TOKUYAMA REBASE II

Cleared Sep 04, 2001

TOKUYAMA M-BOND

Cleared Jul 31, 2001

Cleared Feb 27, 2001

PALFIQUE ESTELITE LV CLEAR

Cleared Jan 04, 2001

PALFIQUE ESTELITE LV

Cleared Feb 02, 2000

TOKUYAMA ONE-UP-BOND F

Cleared Jul 07, 1999

Cleared Aug 24, 1998

TOKUYAMA SOFRELINER

Cleared Apr 27, 1998

PALFIQUE ESTELITE

Cleared Apr 27, 1998

TOKUSO MAC BOND II

Cleared Feb 24, 1998

PALFIQUE ESTELITE PASTE

Cleared Oct 07, 1997

TOKUSO REBASE MR. BOND

Cleared Jan 18, 1996

TOKUYAMA SOFT RELINING

Cleared Oct 02, 1991

PALFIQUE LITEPOSTERIOR

Cleared Oct 02, 1991

Cleared May 29, 1991

PALFIQUE ESTELITE

Cleared May 15, 1991

TOKUSO LIGHT BOND

Cleared May 15, 1990

PALFIQUE LIGHT LINER

Cleared May 15, 1990

Cleared May 15, 1990

PALFIQUE LIGHT BONDING AGENT

Cleared May 15, 1990

PALFIQUE LIGHT COMPOSITE RESIN

Cleared May 15, 1990

PALFIQUE LIGHT-S COMPOSITE RESIN