# K100250: Xceram

- Pathway: 510(k) (Traditional)
- Applicant: Xceramusa
- Decided: Apr 8, 2010 after 71 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: 7 generations back to K830955 (1983). 22 ancestors in all.
No later device cites it as a predicate yet.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070537: Zirblock, Cdl Technologies, Inc. (2007) Summary page 1.
- K092630: ZIROX, Zencera, Inc. (2009) Summary page 1.

## Cited in the summary but kept off the family tree
- K092513: Rainbow Block, Genoss Co., Ltd. (2009). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Indications for use
Used in the manufacture of dental prosthetics: crowns, bridges, inlays, and onlays.

Source page: https://510kreport.com/device/K100250
Methodology: https://510kreport.com/methodology