# K251775: RODIN Cement

- Pathway: 510(k) (Traditional)
- Applicant: Belport Company, Inc., Gingi-Pak
- Decided: Sep 2, 2025 after 84 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Rodin Envision veneer cement (Light Cure): - Permanent adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays and veneers) - Only use Rodin Envision veneer cement Light Cure for restorations with a low thickness of <2mm that have sufficient translucency. Rodin Luting Cement (Dual Cure): - Adhesive luting of glass-ceramic, lithium disilicate glass-ceramic and composite restorations (inlays, onlays, partial crowns, crowns, bridges). - Restorations made of opaque ceramics, e.g. oxide ceramics, can only be permanently cemented if an adhesive is additionally used that is separately light-cured.

Source page: https://510kreport.com/device/K251775
Methodology: https://510kreport.com/methodology