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TopCEM Dual Cure Resin Cement

by Rizhao Huge Biomaterials Company, Ltd.

510(k) K233082

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK233082 Date22 Dec 2023ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
EBF
Device Class
Class II
Regulation
21 CFR Part 872.3690
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

TopCEM Dual Cure Resin Cement is a dental luting resin cement designed for the cementation of various dental restorations. It is suitable for crowns, bridges, inlays, onlays, veneers, and dental posts made from metals, alloys, metal-ceramic, all-ceramic, porcelain, and composite materials.

This dual-cure cement offers both chemical and light-cure capabilities with a working time exceeding 90 seconds and a setting time of 3 minutes. The device is authorized under FDA 510K clearance.

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Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What types of dental restorations is TopCEM suitable for?

    TopCEM Dual Cure Resin Cement is designed for the cementation of various dental restorations, including crowns, bridges, inlays, onlays, veneers, and dental posts. It is compatible with a wide range of materials such as metals, alloys, metal-ceramic, all-ceramic, porcelain, and composite materials.

  • What are the curing characteristics of this resin cement?

    This cement features dual-cure capabilities, meaning it can be set through both chemical and light-cure methods. It provides a working time of over 90 seconds and achieves a full setting time of 3 minutes, allowing clinicians sufficient time for placement and adjustment.

  • What is the regulatory status of TopCEM Dual Cure Resin Cement?

    TopCEM Dual Cure Resin Cement is authorized under FDA 510K clearance, specifically identified by K-number K233082. This indicates that the device has been reviewed and found to be substantially equivalent to legally marketed predicate devices.