Dental Zirconia Ceramic
FDA 510(k) K250811 · Aidite (Qinhuangdao) Technology Co., Ltd.
510(k) numberK250811
Submission
- Device name
- Dental Zirconia Ceramic
- Applicant
- Aidite (Qinhuangdao) Technology Co., Ltd.
Qinhuangdao, CN - Received
- March 17, 2025
- Decision date
- April 11, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K253036 | Light-curing Coloring Materials (ALCM)EBF · Traditional | 04/06/2026SE |
| K251415 | Additively Manufactured Aligner ResinNXC · Traditional | 08/27/2025SE |
| K250534 | Biomic Color OpaqueEIH · Traditional | 05/20/2025SE |
| K250497 | Additive Manufacturing (Light Curing) Crown Bridge ResinEBF · Traditional | 04/30/2025SE |
| K250025 | Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )EIH · Traditional | 03/14/2025SE |
| K242884 | Additively Manufactured Denture ResinEBI · Traditional | 11/22/2024SE |
| K241715 | Dental Glass Ceramics Blocks (HT,LT,ST)EIH · Special | 07/12/2024SE |
| K230115 | Denture Base ResinEBI · Traditional | 03/17/2023SE |
| K223742 | Dental Ceramic BlocksEBF · Traditional | 03/08/2023SE |
| K223477 | PMMA Blocks for Dental UseEBG · Traditional | 02/16/2023SE |
Questions and answers
When was Dental Zirconia Ceramic cleared by the FDA?
Dental Zirconia Ceramic (K250811) received a 510(k) decision of Substantially Equivalent on April 11, 2025, 25 days after the submission was received.
What is the product code of K250811?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.