# K063842: Cyrtina System

- Pathway: 510(k) (Traditional)
- Applicant: Oratio B.V.
- Decided: Apr 17, 2007 after 112 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: 3 generations back to K830955 (1983). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K011394: Lava Frame, Lava Frame Shade, Lava Ceram, Espe Dental AG (2001) Summary page 1.
- K984201: Denzir, Dentronic AB (1999) Summary page 1.
- K001815: DC Zirkon, Austenal, Inc. (2000) Summary page 1.
- K981490: Willi Geller Creation Porcelain, Jensen Industries, Inc. (1998) Summary page 1.
- K994435: Opc 3G All-Ceramic System, Core and Overlay Porcelains, Jeneric/Pentron, Inc. (2000) Summary page 1.
- K982616: Ips Empress 2, Ivoclar North America, Inc. (1998) Summary page 1.
- K011333: Cercon Ceram, Degussa - Ney Dental, Inc. (2001) Summary page 1.
- K050160: Katana Zirconia, Noritake Co., Inc. (2005) Summary page 1.

## Indications for use
The Cyrtina system is intended for CAD/CAM fabrication of allceramic dental restorations. The system is used for the manufacturing of inlays, onlays, veneers, crowns and bridges.

Source page: https://510kreport.com/device/K063842
Methodology: https://510kreport.com/methodology