Ceramill
3D printing material for Crowns and Bridges
9manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (3), Anhui (1), Hong Kong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Anqing Clean Dental Instrument Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 50 |
| Improve Co., Limited | Lantau Island | Hong Kong | Contract manufacturer | 16 |
| Royal Dental Lab | Shenzhen | Guangdong | Manufacturer | 12 |
| Linjiang (Holdings) Limited | Shangqiu | Henan | Private-label distributor | 11 |
| Smart Dental CAD Solutions Limited | Zhuhai | Guangdong | Manufacturer | 8 |
| FOO Tian Dental Laboratory | Shenzhen | Guangdong | Manufacturer | 6 |
| Jintaik (Yunnan) Biotech Co., Ltd. | Kunming | Yunnan | Manufacturer | 5 |
| Xiao Fei Dental Manufacture (Chengdu) Co., Ltd. | Chengdu | Sichuan | Remanufacturer | 5 |
| Shanghai dental labs Inc. | Shanghai | Shanghai | Contract manufacturer | 4 |
Record
| Listed by | Vertex-Dental B.V., Netherlands |
|---|---|
| FDA product code | ELK |
| Device type | Teeth, Artificial, Backing And Facing |
| Device class | Class 1 |
| Regulation | 21 CFR 872.3910 |
| Establishment | Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2019-02-06 |
| Record revised | 2021-10-29 (version 4) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NPAGCMN1.501000 | In distribution | |
| NPAGCMN1.501000 | In distribution | |
| NPAGCMBL01000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| optiprint lumina | Dentona AG | 34 |
| Vertex-Dental BV | Vertex-Dental B.V. | 6 |
| Isotek, MDC Dental | MDC Dental | 2 |
| optiprint I-B-T 385 | Dentona AG | 2 |
| Newtek, MDC Dental | MDC Dental | 2 |
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.