FDA 510(k)

GR-14 Resin System

K-Number: K210298 · 2021-05-05

Decision Date2021-05-05

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

GR-14 Resin System is a medical device manufactured by Pro3Dure Medical GmbH. It received FDA 510(k) clearance on 2021-05-05 under approval number K210298. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GR-14 Resin System?

GR-14 Resin System is a medical device that received FDA 510(k) clearance on 2021-05-05. It is manufactured by Pro3Dure Medical GmbH. The 510(k) number is K210298.

When was GR-14 Resin System approved by the FDA?

GR-14 Resin System received FDA 510(k) clearance on 2021-05-05, under approval number K210298.

What company makes GR-14 Resin System?

GR-14 Resin System is manufactured by Pro3Dure Medical GmbH.

What is the FDA product code for GR-14 Resin System?

The FDA product code for GR-14 Resin System is EBI.

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Other Devices by Pro3Dure Medical GmbH

K201827GR-17 Resin System K211415GR Splint Resin System K212017Thermeo System

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.