# K241204: TopCEM-Veneer Light Cure Veneer Cement

- Pathway: 510(k) (Traditional)
- Applicant: Rizhao Huge Biomaterials Company, Ltd.
- Decided: Jun 28, 2024 after 59 days
- Product code: EMA (Cement, Dental)
- Device class: 2
- Regulation: 21 CFR 872.3275
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K032470 (2003). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142389: Variolink Esthetic, Ivoclar Vivadent, AG (2014) Summary page 5.
- K201790: Dual Cure Resin Cement, Rizhao Huge Biomaterials Company, Ltd. (2020) Summary page 5.

## Indications for use
TopCEM-Veneer Light Cure Veneer Cement is used for permanent cementation of veneer made from materials of porcelain/ceramic and composites.

Source page: https://510kreport.com/device/K241204
Methodology: https://510kreport.com/methodology