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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 the device name listed in this FDA 510(k) record. The listed applicant is Hangzhou Thales Medtech Co., Ltd.. It received FDA 510(k) clearance on 2024-10-03 under 510(k) 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. The listed applicant is Hangzhou Thales Medtech Co., Ltd.. The 510(k) number is K240586.

When did Additive Manufacturing Zirconia Customized Restoration receive FDA 510(k) clearance?

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

Who is the listed applicant for Additive Manufacturing Zirconia Customized Restoration?

The FDA 510(k) record lists Hangzhou Thales Medtech Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

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

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

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Related Devices (Code: ELL)

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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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