# K222686: Perfit FS Dental Zirconia Fully Sintered Block

- Pathway: 510(k) (Special)
- Applicant: Vatech Acucera, Inc.
- Decided: Oct 6, 2022 after 30 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)
- K203590: Perfit FS Dental Zirconia Fully Sintered Block, Vatech Acucera, Inc. (2021) Summary page 4.

## Indications for use
The Perfit FS Dental Zirconia Fully Sintered Block is used for dental restorations using different CAD / CAM or manual milling machines. All blocks are processed through dental laboratories or by dental professionals.

Source page: https://510kreport.com/device/K222686
Methodology: https://510kreport.com/methodology