# K071010: Tizian Ceramic, Flow, Plate, Fix & ZR Blanks

- Pathway: 510(k) (Traditional)
- Applicant: Schutz-Dental GmbH
- Decided: Aug 24, 2007 after 137 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. The FDA summary names no predicate by number.

## Indications for use
Tizian Ceramic is a glass ceramic material, colored to match the VITAPAN® color system. It is used for the ceramic coating of titanium and titanium alloys as well as zirconium dioxide-based frame materials. Tizian ZrBlanks are produced of yttrium oxide-stabilized tetragonal zirconium dioxide in several different sizes for the production of full ceramic crowns, bridges and inlays.

Source page: https://510kreport.com/device/K071010
Methodology: https://510kreport.com/methodology