# K221429: KDF Zirconia Disc

- Pathway: 510(k) (Traditional)
- Applicant: Denken-Highdental Co., Ltd.
- Decided: Jul 14, 2022 after 59 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: 11 generations back to K830955 (1983). 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)
- K171585: LUXEN Zr, LUXEN Smile, Dentalmax Co., Ltd. (2018) Summary page 5.
- K192262: Dental  Zirconia  Blocks, De Corematrix Co., Ltd. (2020) Summary page 5.

## Indications for use
KDF Zirconia Disc is indicated for the production of dental ceramic restorations, specifically inlays, onlays, veneers, artificial teeth, crowns and bridges, which is manufactured by CAD / CAM processing. The application includes both anterior teeth and posterior teeth areas. All blocks are processed by a dental laboratory or dental technician.

Source page: https://510kreport.com/device/K221429
Methodology: https://510kreport.com/methodology