K240586
- 510(k) number
- K240586
- Device name
- Additive Manufacturing Zirconia Customized Restoration
- Applicant
- Hangzhou Thales Medtech Co., Ltd. CN
- Product code
- ELL — Teeth, Porcelain
- Decision date
- 2024-10-03
- Date received
- 2024-03-01
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- Dental
PDFDownload 510(k) SummaryArchived here · 0.5 MB · U.S. public domain
Also available from FDA: K240586.pdf
Official FDA record: K240586
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.