# K213609: NOVA RESIN dual cure, self adhesive resin cement

- Pathway: 510(k) (Traditional)
- Applicant: Imicryl Dis Malzemeleri Sanayi VE Ticaret AS
- Decided: Aug 9, 2022 after 267 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: 1 generation back to K073209 (2008). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073209: Maxcem 2, Kerr Corporation (2008) Summary page 5.

## Indications for use
Nova Resin dual cure, self adhesive resin cement is intended for cementation of all indirect restorations including ceramic, resin and metal-based inlays, onlays, bridges, posts and veneers.* Additional indications include core-buildup material, pit and fissure sealant, and cementation of crowns restorations to implants. *Adhesive application on the prep is required for veneer cementation using Nova Resin dual cure, self adhesive resin cement.

Source page: https://510kreport.com/device/K213609
Methodology: https://510kreport.com/methodology