# K252785: TopCEM Vigor SA Self-Adhesive Resin Cement

- Pathway: 510(k) (Traditional)
- Applicant: Rizhao Huge Biomaterials Company, Ltd.
- Decided: Dec 12, 2025 after 101 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: 10 generations back to K931812 (1993). 31 ancestors in all.
No later device cites it as a predicate yet.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100756: MALTA, 3M Espe AG Dental Products (2010) Summary page 5.

## Indications for use
-Cementation of all-ceramic, composite, and metal crowns, bridges, inlays, onlays, dental posts; 2-3-unite Maryland bridges and 3-unit inlay/onlay bridges (contraindicated for patients with bruxism or periodontitis). -Cementation of fiber posts. -Cementation of all-ceramic, composite, and metal restorations on implant abutments.

Source page: https://510kreport.com/device/K252785
Methodology: https://510kreport.com/methodology