Denture Reline Material

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

510(k) Number

K780786 ↗

FDA Product Code

EBI

Device Class

Class II

Regulation

21 CFR Part 872.3760

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Disposable Screw Type Prophy Brush

  Class I

  FDA 510(k) K900507 Active Cleared 10 Apr 1990

• Sterile Flexofile Files and Instruments

  Class I

  FDA 510(k) K971606 Active Cleared 3 Jun 1997

• Delton F Pit & Fissure Sealant

  Class II

  FDA 510(k) K951296 Active Cleared 3 May 1995

• Fluoride Varnish

  Class II

  FDA 510(k) K031932 Active Cleared 15 Sep 2003

• Dentsply Cavitron Sps Scaler System

  Class II

  FDA 510(k) K970123 Active Cleared 11 Apr 1997

• Delton Fs Direct Delivery System

  Class II

  FDA 510(k) K982564 Active Cleared 6 Oct 1998

See all devices from Dentsply Intl. →

• What is the denture reline material used for?

  The denture reline material is used to resurface the tissue-bearing surface of a denture to improve fit and comfort. It is designed for use in dental applications to reline full or partial dentures, ensuring better adaptation to the oral tissues.

• How is the denture reline material supplied and intended for use?

  The material is supplied for use in dental settings and is intended for single-use application. This means it is designed to be used once per patient and then discarded to maintain hygiene and prevent cross-contamination.

• What regulatory pathway was used for this denture reline material?

  The denture reline material received FDA 510(k) clearance, indicating it was found substantially equivalent to a legally marketed predicate device. The clearance was granted under product code EBI with a traditional review process.