# K240419: UltraThineer Zirconia Slurry (5Y-B)

- Pathway: 510(k) (Traditional)
- Applicant: Boston Micro Fabrication
- Decided: Apr 12, 2024 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: 2 generations back to K051705 (2005). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211308: Inni-Cera, Aon Co., Ltd. (2021) Summary page 5.

## Indications for use
UltraThineer Zirconia Slurry is indicated for use by dental technicians in the construction of custom-made ceramic restorations. These include copings, crowns, inlays and onlays, veneers, and bridges (3-unit anterior bridges).

Source page: https://510kreport.com/device/K240419
Methodology: https://510kreport.com/methodology