Bloomden Bioceramics (Hunan) Co., Ltd.
Manufacturer and brand owner in Changsha, Hunan, China. 1 device type, 1 product catalogued, 2 clearances.
Bloomden Bioceramics (Hunan) 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
2510(k) clearances
Registration
| Registered name | BLOOMDEN BIOCERAMICS (HUNAN) CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3009643402 |
| FEI number | 3009643402 |
| DUNS | 712529058 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 湖南鹏登精密陶瓷有限公司 |
|---|---|
| Unified social credit code | 91430100MA4RJWPX9E |
| Source | NMPA UDI database |
Location
| City | Changsha |
|---|---|
| Province | Hunan |
| Address | No.301, 5th Building, Hi-tech Int’l Enterprise Port, LianDong U Valley |
| Postal code | 410000 |
| Country | China |
What It Makes
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Bloomden | EIH | 6,340 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K260370 | 2026-03-30 | EIH | Traditional | This company |
| K212765 | 2021-11-15 | EIH | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2012 |
|---|---|
| Main products | Dental CAD/CAM zirconia blocks, Zirconia 3D printing, Zirconia implants, Dental restoration materials |
| Certifications | FDA, CFDA, ISO13485, High-tech Enterprise |
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.