# K251593: DenMat Multilayered Zirconia Disc

- Pathway: 510(k) (Traditional)
- Applicant: Denmat Holding, LLC
- Decided: Aug 25, 2025 after 90 days
- Product code: EIH (Powder, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.6660
- 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 K830955 (1983). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231687: Gradual Dental Zirconia Blank, Liaoning Upcera Co., Ltd. (2023) Summary page 5.

## Indications for use
The Multilayered Zirconia Disc is indicated for fabrication of anterior and posterior dental restorations using different CAD/CAM or manual machines. All discs are processed through dental laboratories or by dental professionals.

Source page: https://510kreport.com/device/K251593
Methodology: https://510kreport.com/methodology