Additive Manufacturing Zirconia Customized Restoration— 510(k) K240586
Substantially EquivalentHangzhou Thales Medtech Co., Ltd.
FDA 510(k) clearance K240586 for Additive Manufacturing Zirconia Customized Restoration, Substantially Equivalent on 2024-10-03. Applicant: Hangzhou Thales Medtech Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Hangzhou Thales Medtech Co., Ltd.
- Product code
- Code ELL
- Device class
- Class 2
- Regulation
- 21 CFR 872.3920
- Advisory panel
- Dental
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hangzhou, CN
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Data sourced from openFDA. This site is unofficial and independent of the FDA.