# K240586: Additive Manufacturing Zirconia Customized Restoration

- Pathway: 510(k) (Traditional)
- Applicant: Hangzhou Thales Medtech Co., Ltd.
- Decided: Oct 3, 2024 after 216 days
- Product code: ELL (Teeth, Porcelain)
- Device class: 2
- Regulation: 21 CFR 872.3920
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K910611 (1991). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153534: NobelProcera HT ML Full Contour Zirconia Crown, Nobel Biocare AB (2016) Summary page 6.

## Indications for use
Additive Manufacturing Zirconia Customized Restoration is indicated for use as the core structure of prostheses for partially edentulous patients in need of prosthetic oral reconstruction to restore chewing function and aesthetics. The Additive Manufacturing Zirconia Customized Restoration is a premanufactured prosthetic component and is indicated for use as restorations (Crown, Bridge, Veneer, Inlay) that will be cemented to a natural or artificial tooth abutment.

Source page: https://510kreport.com/device/K240586
Methodology: https://510kreport.com/methodology