Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
FDA 510(k) K212765 · Bloomden Bioceramics (HuNan) Co., Ltd.
510(k) numberK212765
Submission
- Device name
- Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
- Applicant
- Bloomden Bioceramics (HuNan) Co., Ltd.
Changsha, CN - Received
- August 31, 2021
- Decision date
- November 15, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EIH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262074 | Any-ZircosEIH · Traditional | Mediclus Co., Ltd. | 08/21/2026SE |
| K262239 | Obsidian® Press Over ZirconiaEIH · Special | Prismatik Dentalcraft, Inc. | 07/30/2026SE |
| K261046 | Dental Zirconia Blank & Coloring LiquidEIH · Traditional | Hunan Qinghao Puzhong Technology Co., Ltd. | 07/17/2026SE |
| K262195 | Dandy Ceramic Stain and GlazeEIH · Traditional | Zima International Inc., dba Dandy | 06/30/2026SE |
| K260918 | Zolid LunarisEIH · Traditional | Amann Girrbach AG | 06/29/2026SE |
| K260859 | Rosetta SM, Rosetta SPEIH · Traditional | Hass Corp. | 06/11/2026SE |
| K253191 | DCMhotbond zirconEIH · Traditional | Dental Creativ Management GmbH | 05/21/2026SE |
| K260067 | Eternal Art Porcelain PowdersEIH · Traditional | Shandong Huge Dental Material Corporation | 04/09/2026SE |
| K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankEIH · Traditional | Bloomden Bioceramics (HuNan) Co., Ltd. | 03/30/2026SE |
| K253953 | IPS e.max ZirconiaEIH · Traditional | Ivoclar Vivadent, Inc. | 03/10/2026SE |
More from Ivoclar Vivadent, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankEIH · Traditional | 03/30/2026SE |
Questions and answers
When was Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank cleared by the FDA?
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank (K212765) received a 510(k) decision of Substantially Equivalent on November 15, 2021, 76 days after the submission was received.
What is the product code of K212765?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.