AA temp temporary restoration 3D printing photoreactive resin— 510(k) K191590

Name: FDA 510(k) clearance K191590
Creator: U.S. Food and Drug Administration
Published: 2020-05-05

Substantially Equivalent

Enlighten Materials Co., Ltd.

FDA 510(k) clearance K191590 for AA temp temporary restoration 3D printing photoreactive resin, Substantially Equivalent on 2020-05-05. Applicant: Enlighten Materials Co., Ltd.. Device class: 2.

Clearance details

Applicant: Enlighten Materials Co., Ltd.
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2019-06-14
Decision date: 2020-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

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