Katana™ Zirconia Block
KATANA Zirconia Block is a pre-sintered yttria-stabilized zirconia material for fabricating dental restorations. A compatible CEREC milling system shapes the block, and the milled…
KATANA Zirconia Block is a pre-sintered yttria-stabilized zirconia material for fabricating dental restorations. A compatible CEREC milling system shapes the block, and the milled restoration is then sintered before use.
The STML version contains four graded shade layers, while ST is a single-color version. The filed STML 12Z set is one configuration within a family that varies by block size and shade.
Listed Item
STML 12Z Introductory Set Natural
Block and Restoration Options
STML is available in 12Z, 14Z and 14Z L sizes; ST is available in 12Z. The material supports frameworks, full-contour crowns, inlays, onlays and veneers. Full-contour bridge use is limited to the 14Z L size. The blocks are supplied nonsterile.
Who Else Makes It
Concentrated in Guangdong (10), Hunan (6), Hebei (3). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| BMF Tech (Zhuhai) Inc. | Zhuhai | Guangdong | Contract manufacturer | 2 |
| Jiangxi Rekonova Dental Materials Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 1 |
| Aidite (Qinhuangdao) Technology Co., Ltd. | Qinhuangdao | Hebei | Repacker / relabeller | 17 |
| Shandong Huge Dental Material Corporation | Rizhao | Shandong | Manufacturer | 17 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
| Qinhuangdao Audental Metal Technology Co., Ltd. | Qinhuangdao | Hebei | Manufacturer | 11 |
| Liaoning Upcera Co., Ltd. | Benxi | Liaoning | Contract manufacturer | 10 |
| Shenzhen Upcera Digital Dental Technology Co., Ltd. | Shenzhen | Guangdong | Exporter | 10 |
| Rizhao Huge Biomaterials Company, Ltd. | Rizhao | Shandong | Manufacturer | 7 |
| Shenzhen Yurucheng Dental Materials Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
| Hunan Vsmile Biotechnology Co., Ltd. | Changsha | Hunan | Contract manufacturer | 6 |
| Deprag High Tech Materials ( Zhengzhou ) Co., Ltd. | Zhangzhou | Henan | Manufacturer | 6 |
Showing 12 of 33. All 33 manufacturers in China registered for Powder, Porcelain
Record
| Listed by | Kuraray Noritake Dental, Inc., United States |
|---|---|
| FDA product code | EIH |
| Device type | Powder, Porcelain |
| Device class | Class 2 |
| Regulation | 21 CFR 872.6660 |
| 510(k) | K190436 |
| Record published | 2017-08-31 |
| Record revised | 2022-12-19 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Sizes | Width 15.3 to 17.8 mm; height 20.2 mm; length 19.2 to 40 mm |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 125-5901KA | Width 15.3 mm | In distribution |
| 125-5752KA | Length 19.2 mm | In distribution |
| 125-5941KA | Width 15.3 mm | In distribution |
| 125-5972KA | Length 19.2 mm | In distribution |
| 125-6592KA | Length 40.0 mm | In distribution |
| 125-5932KA | Length 19.2 mm | In distribution |
| 125-6722KA | Width 17.8 mm | In distribution |
| 125-5801KA | Width 15.3 mm | In distribution |
| 125-6702KA | Width 17.8 mm | In distribution |
| 125-5821KA | Width 15.3 mm | In distribution |
| 125-5812KA | Length 19.2 mm | In distribution |
| 125-5832KA | Length 19.2 mm | In distribution |
| 125-6692KA | Width 17.8 mm | In distribution |
| 125-5892KA | Length 19.2 mm | In distribution |
| 125-6000KA | Width 15.3 mm | In distribution |
| 125-6612KA | Width 17.8 mm | In distribution |
| 125-5980KA | Width 15.3 mm | In distribution |
| 125-5712KA | Length 19.2 mm | In distribution |
| 125-5792KA | Length 19.2 mm | In distribution |
| 125-5990KA | Length 19.2 mm | In distribution |
| 125-6682KA | Width 17.8 mm | In distribution |
| 125-5761KA | Width 15.3 mm | In distribution |
| 125-5852KA | Length 19.2 mm | In distribution |
| 125-6662KA | Width 17.8 mm | In distribution |
| 125-5741KA | Width 15.3 mm | In distribution |
| 125-5721KA | Width 15.3 mm | In distribution |
| 125-6672KA | Width 17.8 mm | In distribution |
| 125-6602KA | Length 40.0 mm | In distribution |
| 125-5912KA | Length 19.2 mm | In distribution |
| 125-5841KA | Width 15.3 mm | In distribution |
| 125-5772KA | Length 19.2 mm | In distribution |
| 125-5781KA | Width 15.3 mm | In distribution |
| 125-5861KA | Width 15.3 mm | In distribution |
| 125-5701KA | Width 15.3 mm | In distribution |
| 125-6652KA | Width 17.8 mm | In distribution |
| 125-5921KA | Width 15.3 mm | In distribution |
| 125-6642KA | Width 17.8 mm | In distribution |
| 125-5881KA | Width 15.3 mm | In distribution |
| 125-5732KA | Length 19.2 mm | In distribution |
| 125-5872KA | Length 19.2 mm | In distribution |
| 125-6622KA | Width 17.8 mm | In distribution |
| 125-5961KA | Width 15.3 mm | In distribution |
| 125-6712KA | Width 17.8 mm | In distribution |
| 125-6632KA | Width 17.8 mm | In distribution |
| 125-6011KA | Length 19.2 mm | In distribution |
| 125-5952KA | Length 19.2 mm | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Bloomden | Bloomden Bioceramics (Hunan) Co., Ltd. | 6,340 |
| Upcera Dental Zirconia Blank For Aesthetic Restoration | Liaoning Upcera Co., Ltd. | 4,367 |
| Aidite | Aidite (Qinhuangdao) Technology Co., Ltd. | 4,310 |
| Luxen 5G | Dentalmax Co., Ltd. | 3,903 |
| GC Initial™ | GC America Inc. | 2,724 |
| Gradual Dental Zirconia Blank | Liaoning Upcera Co., Ltd. | 2,035 |
| Multi M Series | Dmax Co., Ltd. | 1,854 |
| Zirconia Dental Ceramics | Chengdu Besmile Medical Technology Co., Ltd. | 1,828 |
| Amber® Mill Q | Hass Corp. | 1,602 |
| Upcera Dental Zirconia Pre-Shaded Blank | Liaoning Upcera Co., Ltd. | 1,498 |
| BruxZir | Prismatik Dentalcraft, Inc. | 1,295 |
| ceraMotion® | Dentaurum GmbH & Co. KG | 1,062 |
Showing 12 of 10,017. All products under Powder, Porcelain
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K250673 | 2025-05-29 |
| K220369 | 2022-09-23 |
| K213147 | 2022-03-28 |
| K193060 | 2020-01-30 |
| K190436 | 2019-05-23 |
| K170834 | 2017-10-17 |
| K170986 | 2017-07-13 |
| K143439 | 2015-02-27 |
| K133211 | 2014-03-20 |
| K131534 | 2013-10-11 |
| K121980 | 2012-10-19 |
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.