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TopCEM-Try In Veneer Try-in Gel

by Rizhao Huge Biomaterials Company, Ltd.

510(k) K242572

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 NumberK242572 Date20 Dec 2024ClearedStatusActive

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  • Withdrawn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-Try in Veneer Try-in Gel is a tooth shade resin material. It is used to evaluate the shade and the matching of a restoration prior to permanent cementation.

This device is regulated under product code EBF and has received FDA 510(k) clearance. It is manufactured by Rizhao Huge Biomaterials Company, Ltd. and is classified under the dental medical specialty.

Other devices from Rizhao Huge Biomaterials Company, Ltd.

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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 is the primary purpose of TopCEM-Try in Veneer Try-in Gel?

    This device is a tooth shade resin material designed to help clinicians evaluate the shade and color matching of a dental restoration before the permanent cementation process begins.

  • What is the regulatory status of this dental material?

    TopCEM-Try in Veneer Try-in Gel has received FDA 510(k) clearance under K-number K242572. It is classified under the dental medical specialty and is regulated under product code EBF.

  • Who is the manufacturer of this try-in gel?

    The device is manufactured by Rizhao Huge Biomaterials Company, Ltd., located in Rizhao, China.