GR-17 Resin System— 510(k) K201827

Substantially Equivalent

Pro3Dure Medical GmbH

FDA 510(k) clearance K201827 for GR-17 Resin System, Substantially Equivalent on 2020-11-05. Applicant: Pro3Dure Medical GmbH. Device class: 2.

Clearance details

Applicant: Pro3Dure Medical GmbH
Product code: Code EBG
Device class: Class 2
Regulation: 21 CFR 872.3770
Advisory panel: Dental
Date received: 2020-07-02
Decision date: 2020-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Iserlohn, DE

Download summary PDF View on FDA.gov ↗

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