Data / Medical devices / China / Bloomden Bioceramics (hunan) Co.,ltd.
Bloomden Bioceramics (hunan) Co.,ltd.: FDA-registered device maker in Changsha Hunan, China, 2 510(k) clearances
Bloomden Bioceramics (hunan) Co.,ltd. is registered with the FDA (registration 3009643402) in Changsha Hunan, China. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated March 30, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009643402
- Address
- No.301, 5th Building, Hi-tech Int'l Enterprise Port, LianDong U Valley Linyu Rd, Dongfanghong Street, Hi-tech Development Zone, Changsha Hunan, China, 410000
- Owner or operator
- Bloomden Bioceramics (HuNan) Co.,Ltd. (10083450)
- Roles
- Manufacturer
- First device listed
- November 21, 2021
- Registered through
- 2026
- Brand names listed
- Bloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, MOD: 3D-Pro-ML, UT, UT-C, UT-ML, HTP-plus, Bloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, MOD: 3DP-Pro-ML, UTP, UTP-C, UTP-ML, Bloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, MOD: STP,STP-C,STP-ML,SHTP,SHTP-C,SHTP-ML, Bloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, MOD:HT-plus,ST,ST-C,ST-ML,SHT,SHT-C,SHT-ML, Bloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, model: HT-plus, ST, ST-C, ST-ML, SHT, SHT-C, Bloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, model: SHT-ML, 3D-Pro-ML, UT, UT-C, UT-ML
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powder, Porcelain | EIH | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 30, 2026 | K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | EIH | Substantially Equivalent | Bloomden Bioceramics (HuNan) Co., Ltd. | accessdata.fda.gov |
| November 15, 2021 | K212765 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | EIH | Substantially Equivalent | Bloomden Bioceramics (HuNan) Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated March 30, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.