Additive Manufacturing (Light Curing) Crown Bridge Resin— 510(k) K250497

Name: FDA 510(k) clearance K250497
Creator: U.S. Food and Drug Administration
Published: 2025-04-30

Substantially Equivalent

Aidite (Qinhuangdao) Technology Co., Ltd.

FDA 510(k) clearance K250497 for Additive Manufacturing (Light Curing) Crown Bridge Resin, Substantially Equivalent on 2025-04-30. Applicant: Aidite (Qinhuangdao) Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Aidite (Qinhuangdao) Technology Co., Ltd.
Product code: Code EBF
Device class: Class 2
Regulation: 21 CFR 872.3690
Advisory panel: Dental
Date received: 2025-02-20
Decision date: 2025-04-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Qinhuangdao, CN

Download summary PDF View on FDA.gov ↗

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