# K201790: Dual Cure Resin Cement

- Pathway: 510(k) (Traditional)
- Applicant: Rizhao Huge Biomaterials Company, Ltd.
- Decided: Sep 29, 2020 after 91 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: 2 generations back to K032470 (2003). 2 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K123397: Multilink Automix, Ivoclar Vivadent, AG (2013) Summary page 4.

## Most influential descendants
- K241204: TopCEM-Veneer Light Cure Veneer Cement (2024), 0 descendants of its own
- K233082: TopCEM Dual Cure Resin Cement (2023), 0 descendants of its own

## Indications for use
Dual Cure Resin Cement is a dental luting system designed for cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers, dental posts and other restorations made from materials of metals/alloys, metal- ceramic, all-ceramic and/or porcelain, composites, and their combinations.

Source page: https://510kreport.com/device/K201790
Methodology: https://510kreport.com/methodology