PMMA Block— 510(k) K201683

Substantially Equivalent

Huge Dental Material Co., Ltd.

FDA 510(k) clearance K201683 for PMMA Block, Substantially Equivalent on 2020-11-03. Applicant: Huge Dental Material Co., Ltd.. Device class: 2.

Clearance details

Applicant: Huge Dental Material Co., Ltd.
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2020-06-22
Decision date: 2020-11-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rizhao City, CN

Download summary PDF View on FDA.gov ↗

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