Zirdent NEW Material Co., Ltd.
Manufacturer and brand owner in Changsha, Hunan, China. 1 device type, 1 product catalogued, 1 clearance.
Zirdent NEW Material Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Powder, Porcelain. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2021.
1device type
1product
1510(k) clearance
Registration
| Registered name | ZIRDENT NEW MATERIAL CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3021284321 |
| FEI number | 3021284321 |
| DUNS | 699451090 |
| Establishment type | Manufacturer |
Location
| City | Changsha |
|---|---|
| Province | Hunan |
| Address | 1st & 2nd floor, Building 5, Changsha Medical device Industrial Area,No.88, Section 1,Tengfei Road |
| Postal code | 410200 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Powder, Porcelain | Class 2 | Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, Zirconia Blocks, Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | 2021 | 33 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | EIH | 12 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K212259 | 2021-11-12 | EIH | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2020 |
|---|---|
| Employees | 100+ |
| Factory area | 7600 |
| Main products | dental zirconia blocks, dental milling machines, sintering furnaces, dental scanners, consumables |
| Certifications | CE MDR, FDA Cleared, ISO 13485:2016 |
| Export markets | Global (2 million+ cases) |
| OEM and ODM | Offered |
Nearby Manufacturers
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.
The manufacturer named here can complete this record.