Multi-Cure Composite Cement

No FDA recalls on record, checked 22 Oct 2026.

510(k) Number

K990314 ↗

FDA Product Code

EBF

Device Class

Class II

Regulation

21 CFR Part 872.3690

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

• Zinc Phosphate Cement

  Class II

  FDA 510(k) K983018 Active Cleared 22 Oct 1998

• Chemical Cure Composite with Enamel Bond

  Class II

  FDA 510(k) K982191 Active Cleared 14 Sep 1998

• Cavity Varnish (Intermediary Varnish and Dentinal Tubuli Seal)

  Class II

  FDA 510(k) K973919 Active Cleared 16 Dec 1997

• Medental Chemical Curing Sealant Pit & Fissure Tinted

  Class II

  FDA 510(k) K973541 Active Cleared 25 Nov 1997

• Polycarboxylate Cement

  Class II

  FDA 510(k) K980990 Active Cleared 31 Jul 1998

• Medental Glass Ionomer Cement Type I and Mirage Glass Ionomer Cement Type 1

  Class II

  FDA 510(k) K982779 Active Cleared 30 Sep 1998

• What is Multi-Cure Composite Cement used for?

  Multi-Cure Composite Cement is a dual cure resin cement used for the permanent cementation of dental restorations including composites, crowns, bridges, veneers, inlays, and onlays. It provides secure fixation of restorations with a working time suitable for dental procedures.

• How is Multi-Cure Composite Cement supplied?

  The device is supplied by Medental Intl. and has received FDA 510(k) clearance with product code EBF. It is intended for use in dental applications and is regulated as a substantially equivalent device under the advisory committee for dental products.

• Is Multi-Cure Composite Cement single-use or reusable?

  The device information does not specify whether Multi-Cure Composite Cement is single-use or reusable. For proper usage and disposal instructions, please refer to the product's labeling or contact the manufacturer directly.

• What regulatory approvals does Multi-Cure Composite Cement have?

  Multi-Cure Composite Cement has received FDA 510(k) clearance with product code EBF. It is regulated as a substantially equivalent device under the advisory committee for dental products with the decision code SESE.