Additive Manufacturing Zirconia Customized Restoration
FDA 510(k) clearance K240586 · decided 2024-10-03
Clearance details
- K-number
- K240586
- Device name
- Additive Manufacturing Zirconia Customized Restoration
- Applicant
- Hangzhou Thales Medtech Co., Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-03-01
- Decision date
- 2024-10-03
- Days to decision
- 216 days
- Clearance type
- Traditional
- Product code
- ELL
- Device class
- 2
- Regulation number
- 872.3920
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Hangzhou, CN
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.