Clearance Summary
Additive Manufacturing Zirconia Customized Restoration received FDA 510(k) clearance under submission number K240586, sponsored by Hangzhou Thales Medtech Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2024-10-03.
- Submission: K240586
- Applicant / Sponsor: Hangzhou Thales Medtech Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3920
- Decision date: 2024-10-03
Classification & Regulation
This clearance is catalogued under FDA product code ELL and 21 CFR 872.3920, within the Dental review panel as a Class II device.