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FDA 510(k)

Additive Manufacturing Zirconia Customized Restoration

K-Number: K240586 · 2024-10-03

ApplicantHangzhou Thales Medtech Co., Ltd.
Decision Date2024-10-03
Product CodeELL
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Additive Manufacturing Zirconia Customized Restoration is a medical device manufactured by Hangzhou Thales Medtech Co., Ltd.. It received FDA 510(k) clearance on 2024-10-03 under approval number K240586. The device is classified under product code ELL. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Additive Manufacturing Zirconia Customized Restoration?

Additive Manufacturing Zirconia Customized Restoration is a medical device that received FDA 510(k) clearance on 2024-10-03. It is manufactured by Hangzhou Thales Medtech Co., Ltd.. The 510(k) number is K240586.

When was Additive Manufacturing Zirconia Customized Restoration approved by the FDA?

Additive Manufacturing Zirconia Customized Restoration received FDA 510(k) clearance on 2024-10-03, under approval number K240586.

What company makes Additive Manufacturing Zirconia Customized Restoration?

Additive Manufacturing Zirconia Customized Restoration is manufactured by Hangzhou Thales Medtech Co., Ltd..

What is the FDA product code for Additive Manufacturing Zirconia Customized Restoration?

The FDA product code for Additive Manufacturing Zirconia Customized Restoration is ELL.

Related Clinical Trials

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Related PubMed Literature

PMID: 41596046 A Review of 3D-Printed Medical Devices for Cancer Radiation Therapy. Bioengineering (Basel, Switzerland) (2026) PMID: 26243449 Regulatory Considerations in the Design and Manufacturing of Implantable 3D-Printed Medical Devices. Clinical and translational science (2015)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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