Manufacturer registered with FDA
Zirdent New Material Co.,Ltd
Changsha, China. Lists 1 dental device type with FDA across 1 registered establishment, and holds 1 510(k) clearance as applicant.
- Device types listed
- 1
- Brands and models
- 3
- 510(k) clearances
- 12021–2021
- Markets registered in
- 43 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name Zirdent New Material Co.,Ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Zirdent New Material Co.,Ltd | 1 clearances | 2021–2021 | Below |
| European Union | EUDAMED | Manufacturer | Zirdent New Material Co.,Ltd. | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Zirdent New Material Co., Ltd. | 1 | 2026–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Zirdent New Material Co., Ltd. | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Zirdent New Material Co.,Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankZirconia BlocksZirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Zirdent New Material Co.,Ltd as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 12 Nov 2021 | K212259 | Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | EIH Porcelain Powder |
Some of these clearances are listed with FDA today by another company: DEPRAG High tech Materials ( Zhengzhou ) Co.,Ltd. (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ZIRDENT NEW MATERIAL CO.,LTDFDA reg. 3021284321 | Changsha Hunan, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10083428). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.