Manufacturer registered with FDA
Bloomden Bioceramics (HuNan) Co.,Ltd.
Changsha, China. Lists 1 dental device type with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 6
- 510(k) clearances
- 22021–2026
- Markets registered in
- 921 registrations outside the US
- Establishments
- 1China
510(k) clearances per year, 2007–2026
Registered in 9 markets
Where regulators' registries name Bloomden Bioceramics (HuNan) 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 | Bloomden Bioceramics (HuNan) Co.,Ltd. | 2 clearances | 2021–2026 | Below |
| Egypt | EDA | Manufacturer | Bloomden Bioceramics (HuNan) Co.,Ltd. ,Bloomden Bioceramics (HuNan) Co.,Ltd., | 11 | 2026–2026 | Pure Global AI |
| Canada | Health Canada | Registration holder | BLOOMDEN BIOCERAMICS (HUNAN) CO., LTD | 2 | 2025–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | Bloomden Bioceramics (HuNan) Co., Ltd. | 2 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | Bloomden Bioceramics (HuNan) Co., Ltd. | 2 | 2026–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Bloomden Bioceramics (HuNan) Co Ltd | 1 | 2025–2025 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Bloomden Bioceramics (HuNan) Co.,Ltd | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Bloomden Bioceramics (HuNan) Co., Ltd. | 1 | 2025–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Bloomden Bioceramics (HuNan) 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 Bloomden Bioceramics (HuNan) 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 | Bloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, MOD: 3D-Pro-ML, UT, UT-C, UT-ML, HTP-plusBloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, MOD: 3DP-Pro-ML, UTP, UTP-C, UTP-MLBloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, MOD: STP,STP-C,STP-ML,SHTP,SHTP-C,SHTP-MLBloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, MOD:HT-plus,ST,ST-C,ST-ML,SHT,SHT-C,SHT-MLBloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, model: HT-plus, ST, ST-C, ST-ML, SHT, SHT-CBloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, model: SHT-ML, 3D-Pro-ML, UT, UT-C, UT-ML | 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 Bloomden Bioceramics (HuNan) Co.,Ltd. as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BLOOMDEN BIOCERAMICS (HUNAN) CO.,LTD.FDA reg. 3009643402 | Changsha Hunan, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10083450). 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.