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FDA 510(k)

GR-14 Resin System

K-Number: K210298 · 2021-05-05

ApplicantPro3Dure Medical GmbH
Decision Date2021-05-05
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GR-14 Resin System is the device name listed in this FDA 510(k) record. The listed applicant is Pro3Dure Medical GmbH. It received FDA 510(k) clearance on 2021-05-05 under 510(k) 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. The listed applicant is Pro3Dure Medical GmbH. The 510(k) number is K210298.

When did GR-14 Resin System receive FDA 510(k) clearance?

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

Who is the listed applicant for GR-14 Resin System?

The FDA 510(k) record lists Pro3Dure Medical GmbH as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Pro3Dure Medical GmbH as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231775GR Resin System MSIK212017Thermeo SystemK211415GR Splint Resin SystemK201827GR-17 Resin System

Related Devices (Code: EBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.K260376Denture BaseShandong Huge Dental Material Corporation

Official Source

View on FDA Database →

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

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