ELL
- Product code
- ELL
- Device name
- Teeth, Porcelain
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.3920
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 39
510(k) clearances, last 3 years (1)
| Number | Decision date | Applicant | Device name |
|---|---|---|---|
| K240586 | 2024-10-03 | Hangzhou Thales Medtech Co., Ltd. | Additive Manufacturing Zirconia Customized Restorati summary |
Official FDA classification page: ELL
Classification and pathway per current FDA publications. Data from openFDA (CC0).