# K113431: Ceramic Products Made in Yttria-Stabilized Zirconia

- Pathway: 510(k) (Traditional)
- Applicant: Bettini S.P.A.
- Decided: Mar 30, 2012 after 130 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Bettini BZD Zirconia Blocks are indicated for use in preparation of crowns, facings, inlays, and onlays to produce a hard prosthesis with a porcelain-like finish. The blocks are frequently used with porcelain overlay for translucence and related effects, and they are utilized to fabricate copings and frameworks for inlays, onlays, veneers, crowns, and anterior and posterior bridge restorations.

Source page: https://510kreport.com/device/K113431
Methodology: https://510kreport.com/methodology