EIH — Powder, Porcelain Class II
FDA product code EIH covers "Powder, Porcelain", a Class II medical device regulated under 21 CFR 872.6660. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EIH
- Device Class
- Class II
- Regulation Number
- 872.6660
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K261046 | hunan qinghao puzhong technology co | Dental Zirconia Blank & Coloring Liquid | July 17, 2026 |
| K262195 | zima international inc., dba dandy | Dandy Ceramic Stain and Glaze | June 30, 2026 |
| K260918 | amann girrbach | Zolid Lunaris | June 29, 2026 |
| K260859 | hass | Rosetta SM, Rosetta SP | June 11, 2026 |
| K253191 | dental creativ management | DCMhotbond zircon | May 21, 2026 |
| K260067 | shandong huge dental material corporation | Eternal Art Porcelain Powders | April 9, 2026 |
| K260370 | bloomden bioceramics (hunan) co | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | March 30, 2026 |
| K253953 | ivoclar vivadent | IPS e.max Zirconia | March 10, 2026 |
| K254283 | prismatik dentalcraft | BruxZir® Shaded 16 PLUS | January 30, 2026 |
| K253973 | liaoning upcera co | Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series | January 9, 2026 |
| K252789 | shenzhen xiangtong co | Glass Ceramic | December 8, 2025 |
| K252446 | prismatik dentalcraft | BruxZir® NOW | September 3, 2025 |
| K251593 | denmat holding | DenMat Multilayered Zirconia Disc | August 25, 2025 |
| K250063 | arum dentistry co | ARENA Star, Galaxy Star | July 10, 2025 |
| K250826 | dmax co | Multi M Series | June 12, 2025 |
| K251084 | estetic ceram | zirkon; structure; LFU shades, stains and glazes | June 5, 2025 |
| K250673 | kuraray noritake dental | CERABIEN MiLai | May 29, 2025 |
| K250534 | aidite (qinhuangdao) technology co | Biomic Color Opaque | May 20, 2025 |
| K250393 | united zirconia | ZircaGlow & ZircaGlow HT Zirconia | May 12, 2025 |
| K250811 | aidite (qinhuangdao) technology co | Dental Zirconia Ceramic | April 11, 2025 |