Katana™ Zirconia ONE
KATANA Zirconia ONE For IMPLANT is a presintered zirconia block for making the ceramic portion of a two piece titanium base abutment. Trained professionals mill a patient matched…
KATANA Zirconia ONE For IMPLANT is a presintered zirconia block for making the ceramic portion of a two piece titanium base abutment. Trained professionals mill a patient matched mesostructure for a hybrid abutment or hybrid abutment crown.
The block works with specified Sirona TiBase components and the compatible Sirona CAD/CAM workflow. It is offered in one block size with small or large access holes and several tooth shades.
Listed Item
For IMPLANT L A3.5
Assembly and Sterilization
The milled ceramic component is cemented to the titanium base using the specified PANAVIA SA Cement Universal. The completed abutment must be sterilized after cementation. The zirconia block is therefore a manufacturing component rather than a finished implant fixture.
Who Else Makes It
Concentrated in Guangdong (11), Jiangsu (2), Shanghai (1). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| LX Precision Shanghai Co Ltd | Shanghai | Shanghai | Contract manufacturer | 19 |
| Modern Dental Laboratory (DG) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 15 |
| Exceldent Dental Technology Development Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 12 |
| DTS Digital Dental LAB | Shenzhen | Guangdong | Contract manufacturer | 11 |
| KTJ Medical Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 11 |
| Shimmer Computerized Dental Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 10 |
| Zhuhai Crystal Dental Technology Co., Ltd. | Zhuhai | Guangdong | Contract manufacturer | 9 |
| NEW Perfect Dental LAB | Shenzhen | Guangdong | Contract manufacturer | 8 |
| Shenzhen Jiahong Dental Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Jiangsu Trausim Medical Instrument Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 3 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| CBD Dental LAB, Inc | Shenzhen | Guangdong | Manufacturer | 11 |
Showing 12 of 15. All 15 manufacturers in China registered for Abutment, Implant, Dental, Endosseous
Record
| Listed by | Kuraray Noritake Dental, Inc., United States |
|---|---|
| FDA product code | NHA |
| Device type | Abutment, Implant, Dental, Endosseous |
| Device class | Class 2 |
| Regulation | 21 CFR 872.3630 |
| 510(k) | K233285 |
| Record published | 2024-11-21 |
Specifications
| MRI safety | MR Conditional |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 125-9693KA | Width:22.1 Millimeter | In distribution |
| 125-9680KA | Width:22.1 Millimeter | In distribution |
| 125-9699KA | Width:22.1 Millimeter | In distribution |
| 125-9696KA | Width:22.1 Millimeter | In distribution |
| 125-9685KA | Width:22.1 Millimeter | In distribution |
| 125-9683KA | Width:22.1 Millimeter | In distribution |
| 125-9682KA | Width:22.1 Millimeter | In distribution |
| 125-9687KA | Width:22.1 Millimeter | In distribution |
| 125-9695KA | Width:22.1 Millimeter | In distribution |
| 125-9686KA | Width:22.1 Millimeter | In distribution |
| 125-9698KA | Width:22.1 Millimeter | In distribution |
| 125-9689KA | Width:22.1 Millimeter | In distribution |
| 125-9690KA | Width:22.1 Millimeter | In distribution |
| 125-9688KA | Width:22.1 Millimeter | In distribution |
| 125-9681KA | Width:22.1 Millimeter | In distribution |
| 125-9697KA | Width:22.1 Millimeter | In distribution |
| 125-9692KA | Width:22.1 Millimeter | In distribution |
| 125-9691KA | Width:22.1 Millimeter | In distribution |
| 125-9684KA | Width:22.1 Millimeter | In distribution |
| 125-9694KA | Width:22.1 Millimeter | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MEDENTiKA | Medentika GmbH | 2,553 |
| LW Vis Abutment | Ossvis Co., Ltd. | 2,520 |
| Dess dental smart solutions | Terrats Medical SL | 1,715 |
| Locator | Zest Anchors, LLC | 1,643 |
| NobelProcera® | Nobel Biocare AB | 1,526 |
| Azure | Terrats Medical SL | 1,360 |
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 1,308 |
| LW Vis Abutment SET | Ossvis Co., Ltd. | 1,260 |
| Abutment, Implant, Dental, Endosseous | Southern Implants (PTY) Ltd | 1,240 |
| Healing Abutment | Megagen Implant Co., Ltd. | 1,218 |
| Chaorum Implant System | Medimecca Co Ltd | 1,084 |
| OT Equator | Rhein 83 SRL | 1,051 |
Showing 12 of 6,204. All products under Abutment, Implant, Dental, Endosseous
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K233285 | 2024-05-24 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.