EIH — Powder, Porcelain Class II
FDA Device Classification
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 |
|---|
| 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 |
| K250025 | aidite (qinhuangdao) technology co | Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid ) | March 14, 2025 |
| K250223 | prismatik dentalcraft | BruxZir® Esthetic NOW | February 25, 2025 |
| K243940 | vita zahnfabrik h.rauter gmbh and | VITA YZ Multi Translucent | February 21, 2025 |
| K242740 | liaoning rachcera material technology co | Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) | December 5, 2024 |
| K242521 | osstem implant co | Estar-ZE | November 20, 2024 |
| K242407 | hunan vsmile biotechnology co | Dental Glass Ceramics Blocks (HT, LT, MT) | November 13, 2024 |
| K242462 | dentsply sirona | CEREC Cercon 4D CAD/CAM Blocks | October 24, 2024 |