Eternal Art Porcelain Powders
FDA 510(k) K260067 · Shandong Huge Dental Material Corporation
510(k) numberK260067
Submission
- Device name
- Eternal Art Porcelain Powders
- Applicant
- Shandong Huge Dental Material Corporation
Rizhao City, CN - Received
- January 9, 2026
- Decision date
- April 9, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded BlankEIH · Traditional | Bloomden Bioceramics (HuNan) Co., Ltd. | 03/30/2026SE |
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More from Prismatik Dentalcraft, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K260376 | Denture BaseEBI · Traditional | 05/06/2026SE |
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| K220680 | Denture Base PolymersEBI · Traditional | 08/12/2022SE |
| K213994 | Flexible BlockEBI · Traditional | 03/04/2022SE |
| K201684 | A-Silicone for Bite RegistrationELW · Traditional | 09/24/2020SE |
| K181747 | Orthodontic ApplianceNXC · Traditional | 04/18/2019SE |
| K160345 | Glass Ionomer CementEMA · Traditional | 03/03/2017SE |
| K161851 | Glass Ionomer Cement (Luting)EMA · Traditional | 10/31/2016SE |
Questions and answers
When was Eternal Art Porcelain Powders cleared by the FDA?
Eternal Art Porcelain Powders (K260067) received a 510(k) decision of Substantially Equivalent on April 9, 2026, 90 days after the submission was received.
What is the product code of K260067?
The FDA product code is EIH – Powder, Porcelain, a Class II (moderate risk) device regulated under 21 CFR 872.6660.