Tokuyama Sofreliner

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

510(k) Number

K982537 ↗

FDA Product Code

EBI

Device Class

Class II

Regulation

21 CFR Part 872.3760

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 Tokuyama Sofreliner used for?

  Tokuyama Sofreliner is a chairside soft denture reline material designed to provide comfort for denture wearers by creating a soft, smooth surface that reduces irritation and improves fit.

• How is Tokuyama Sofreliner supplied and applied?

  Tokuyama Sofreliner is supplied for chairside application in dental settings. It is an addition-cured silicone material that adheres firmly to dentures and is designed to be long-lasting with resistance to staining and odor.

• What consistencies is Tokuyama Sofreliner available in?

  Tokuyama Sofreliner is available in both soft and medium consistencies, allowing dental professionals to choose the appropriate material based on patient needs and preferences.

• What is the regulatory status of Tokuyama Sofreliner?

  Tokuyama Sofreliner has FDA 510(k) clearance with product code EBI, indicating it has been determined to be substantially equivalent to predicate devices for its intended use.