TEMP MASTER, PMMA-based dental resin— 510(k) K243951

Name: FDA 510(k) clearance K243951
Creator: U.S. Food and Drug Administration
Published: 2025-02-21

Substantially Equivalent

Taiwan Dental Materials Co., Ltd.

FDA 510(k) clearance K243951 for TEMP MASTER, PMMA-based dental resin, Substantially Equivalent on 2025-02-21. Applicant: Taiwan Dental Materials Co., Ltd.. Device class: 2.

Clearance details

Applicant: Taiwan Dental Materials Co., Ltd.
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2024-12-23
Decision date: 2025-02-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taipei, TW

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.