Additive Manufacturing Zirconia Customized Restoration— 510(k) K240586

Substantially Equivalent

Hangzhou 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..

Clearance details

Applicant: Hangzhou Thales Medtech Co., Ltd.
Product code: Code ELL
Advisory panel: Dental
Date received: 2024-03-01
Decision date: 2024-10-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hangzhou, CN

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