# K133268: Tizian Blank, Tizian Zirconium Reinforced Composite Blank, Tizian Color Blank, Tizian Blank Occlusal, Tizian Blank Trans

- Pathway: 510(k) (Traditional)
- Applicant: Schutz-Dental GmbH
- Decided: Feb 12, 2015 after 476 days
- Product code: EBG (Crown And Bridge, Temporary, Resin)
- Device class: 2
- Regulation: 21 CFR 872.3770
- 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
Tizian Blank Zirconia Reinforced Composite is made of a composite material reinforced with zirconium dioxide. The blanks can be processed with CAD/CAM technology. Optionally, the blanks can be veneered with a composite or with a monolithic material. Applications are: 1) long-term temporaries (for up to 2 years) o up to 16-unit anterior and posterior crowns and bridges, fully anatomic or reduced o only up to 2 bridge units in the posterior sector o free-end bridges with no more than one attachment 2) small permanent restorations (those must be veneered with an incisal material) o individual crowns o inlays o onlays o veneers o bridges with a maximum of 3 units.

Source page: https://510kreport.com/device/K133268
Methodology: https://510kreport.com/methodology