# K050203: ALLUX

- Pathway: 510(k) (Traditional)
- Applicant: Wieland Dental + Technik GmbH & Co. KG
- Decided: Feb 14, 2005 after 17 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: 1 generation back to K944702 (1994). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K944702: Procera All-Ceramic Porcelain, Nobelpharma USA, Inc. (1994) Summary page 1.

## Indications for use
Allux® is a dental silicate-glass ceramic that can be used by dental technicians to fabricate all-ceramic restorations by veneering aluminium oxide (AI 203 ) frameworks. The coefficient of thermal expansion [CTE (25 - 500°C)] of these aluminium oxide (A12 0 3) frameworks had to equal approximately 8.0 x 10'IK .

Source page: https://510kreport.com/device/K050203
Methodology: https://510kreport.com/methodology