Palfique Light Composite Resin

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K897010 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Palfique Light Liner

  Class II

  FDA 510(k) K896980 Active Cleared 15 May 1990

• Bistite II Sc

  Class II

  FDA 510(k) K991711 Active Cleared 7 Jul 1999

• Palfique Estelite

  Class II

  FDA 510(k) K980054 Active Cleared 27 Apr 1998

• Tokuso Light Bond

  Class II

  FDA 510(k) K911525 Active Cleared 15 May 1991

• Palfique Inlay

  Class II

  FDA 510(k) K913100 Active Cleared 2 Oct 1991

• Tokuyama Soft Relining

  Class II

  FDA 510(k) K953589 Active Cleared 18 Jan 1996

See all devices from Tokuyama America, Inc. →

• What is PALFIQUE LIGHT COMPOSITE RESIN used for?

  PALFIQUE LIGHT COMPOSITE RESIN is indicated for use in dental restorative procedures, specifically for anterior and posterior restorations, as a light-cured, radiopaque, submicron filled composite resin material engineered by Tokuyama Dental.

• How is PALFIQUE LIGHT COMPOSITE RESIN supplied and what is its regulatory status?

  The device is supplied as a composite resin material and received FDA 510(k) clearance under K897010 with product code EBF, determined to be substantially equivalent to a predicate device through a traditional clearance process.

• Is PALFIQUE LIGHT COMPOSITE RESIN sterile or single-use?

  The provided data does not specify sterility or single-use/reuse characteristics for PALFIQUE LIGHT COMPOSITE RESIN; therefore, no conclusion can be drawn about its sterility or usage limitations from the given information.