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Pro3dure Medical GMBH: FDA-registered device maker in Iserlohn North Rhine-Westphalia, Germany, 5 510(k) clearances

Name: Pro3dure Medical GMBH FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Pro3dure Medical GMBH is registered with the FDA (registration 3014888923) in Iserlohn North Rhine-Westphalia, Germany. It lists 11 device types. The FDA files 5 510(k) clearances under its listings, the newest dated August 8, 2024. Registered through 2026. FDA data exported November 3, 2026.

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FDA registration number: 3014888923
Address: Am Burgberg 13, Iserlohn North Rhine-Westphalia, Germany, 58642
Owner or operator: pro3dure medical GmbH (10059691)
Roles: Manufacturer
First device listed: February 12, 2019
Registered through: 2026
Brand names listed: ACRY Print RU-001 temporary, ACRY Print RU-003 Try-In, ACRY Print RU-004 Denture HI, ACRY Print RU-005 Guide, BEGO PMMA Splint E, CORiTEC splint comfort, FLOW C&B, FLOW Denture and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Implant, Dental, Endosseous	NDP	1	Manufacturer	accessdata.fda.gov
Additively Manufactured, Preformed, Resin Denture Tooth	PZY	2	Manufacturer	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Manufacturer	accessdata.fda.gov
Hearing Aid, Air-Conduction, Prescription	ESD	1	Manufacturer	accessdata.fda.gov
Kit, Earmold, Impression	LDG	1	Manufacturer	accessdata.fda.gov
Maintainer, Space Preformed, Orthodontic	DYT	1	Manufacturer	accessdata.fda.gov
Material, Impression Tray, Resin	EBH	1	Manufacturer	accessdata.fda.gov
Mouthguard, Prescription	MQC	U	Manufacturer	accessdata.fda.gov
Plate, Base, Shellac	EEA	1	Manufacturer	accessdata.fda.gov
Positioner, Tooth, Preformed	KMY	1	Manufacturer	accessdata.fda.gov
Resin, Denture, Relining, Repairing, Rebasing	EBI	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 8, 2024	K231775	GR Resin System MSI	MQC	Substantially Equivalent	Pro3Dure Medical	accessdata.fda.gov
April 8, 2022	K212017	Thermeo System	MQC	Substantially Equivalent	Pro3Dure Medical GmbH	accessdata.fda.gov
October 21, 2021	K211415	GR Splint Resin System	MQC	Substantially Equivalent	Pro3Dure Medical GmbH	accessdata.fda.gov
May 5, 2021	K210298	GR-14 Resin System	EBI	Substantially Equivalent	Pro3Dure Medical GmbH	accessdata.fda.gov
November 5, 2020	K201827	GR-17 Resin System	EBG	Substantially Equivalent	Pro3Dure Medical GmbH	accessdata.fda.gov

Compare with other makers

Updated August 8, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.