# K103773: Zenoflex Dimension

- Pathway: 510(k) (Abbreviated)
- Applicant: Wieland Dental + Technik GmbH & Co. KG
- Decided: Mar 16, 2011 after 79 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 K031968 (2003). 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)
- K051249: ZIROX, Wieland Dental + Technik GmbH & Co. KG (2005) Summary page 1.

## Indications for use
Zenoflex dimension is a dental ceramic, which is suitable for veneering hard-sintered zirconium dioxide frameworks with a coefficient of thermal expansion (CTE 25-500 0C) of approx. 1.5 X10-6 K-1.

Source page: https://510kreport.com/device/K103773
Methodology: https://510kreport.com/methodology