# K070772: Pressx ZR

- Pathway: 510(k) (Traditional)
- Applicant: Wieland Dental + Technik GmbH & Co. KG
- Decided: Apr 30, 2007 after 40 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.
10 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K123952: Cerec Blocs C in (2013), 9 descendants of its own
- K141727: Dental Lithium Disilicate Glass Ceramic Block (UP. Press Series and UP. Cad Series) (2014), 8 descendants of its own
- K192231: Dental Glass Ceramics Blocks (2020), 5 descendants of its own
- K242407: Dental Glass Ceramics Blocks (HT, LT, MT) (2024), 0 descendants of its own
- K241715: Dental Glass Ceramics Blocks (HT,LT,ST) (2024), 0 descendants of its own

## Indications for use
PressX Zr is a pressable dental ceramic that can be used by dental technicians to fabricate all-ceramic restorations by pressing-over zirconium dioxide frameworks. The indications of these all-ceramic restorations are defined by the manufacturers of the zirconium dioxide (ZrO2) framework material, and normally encompass dental crowns and bridges. The coefficient of thermal expansion [CTE (25 - 500°C)] of these zirconium dioxide (ZrO 2) frameworks has to equal approximately 10x 10' 61C 1 In addition, PressX Zr can be used to manufacture all-ceramic inlays, onlays, and veneers without zirconium dioxide frameworks.

Source page: https://510kreport.com/device/K070772
Methodology: https://510kreport.com/methodology