# K233285: KATANA Zirconia ONE For IMPLANT

- Pathway: 510(k) (Traditional)
- Applicant: Kuraray Noritake Dental, Inc.
- Decided: May 24, 2024 after 238 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 13 generations back to K894844 (1990). 122 ancestors in all.
No later device cites it as a predicate yet.
0 of 123 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193408: Sirona Dental CAD/CAM System with CEREC Chairside Software, Dentsply Sirona (2020) Summary page 6.

## Indications for use
KATANA Zirconia ONE For IMPLANT is intended for use in partially or fully edentulous mandibles and maxillae in support of single cement-retained restorations. For the SBL 3.3 L titanium bases, the indication is restricted to the replacement of single lateral incisors in the maxilla and lateral and central incisors in the mandible. KATANA Zirconia ONE For IMPLANT is used in combination with the TiBase and Sirona Dental CAD/CAM System. KATANA Zirconia ONE For IMPLANT cemented to the TiBase is recommended for two-piece hybrid abutments for single tooth restorations and hybrid abutment crowns, used in conjunction with endosseous dental implants. Compatible implant systems and TiBase are as follows.

Source page: https://510kreport.com/device/K233285
Methodology: https://510kreport.com/methodology