# K233082: TopCEM Dual Cure Resin Cement

- Pathway: 510(k) (Traditional)
- Applicant: Rizhao Huge Biomaterials Company, Ltd.
- Decided: Dec 22, 2023 after 87 days
- Product code: EBF (Material, Tooth Shade, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3690
- 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). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052820: Parapost Paracore Automix 5ML, Coltene/Whaledent AG (2006) Summary page 5.
- K201790: Dual Cure Resin Cement, Rizhao Huge Biomaterials Company, Ltd. (2020) Summary page 5.

## Indications for use
- Permanent cementation of all sorts of dental restorations including crowns, bridges, inlays/onlays, veneers and other restorations made from materials of metals/alloys, metal-ceramic, all-ceramic and/or porcelain, composites, and their combinations. - Permanent cementation for all types of root canal posts. - Core build-ups.

Source page: https://510kreport.com/device/K233082
Methodology: https://510kreport.com/methodology