Pro3dure Medical G M B H

FDA Filings

This page includes the latest FDA filings for Pro3dure Medical G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3014888923
• FEI Number: 3014888923
• Name: PRO3DURE MEDICAL GMBH
• Owner & Operator: pro3dure medical GmbH
• Contact Address: Am Burgberg 13 ; Iserlohn DE-NW Nordrhein-Westfalen 58642 DE
• Official Correspondent:
  • Andreas Faber
  • 049-2374-928847-x
• US Agent:
  • Scott Giller
  • 952 4261928
  • 952 6817515
  • scott.giller@pro3dure.com
• Importing Logistics Registration:
  • Importer: pro3dure medical LLC
  • Address: 9825 Valley View Road ; Eden Prairie, MN 55344 UNITED STATES
  • Email Address: scott.giller@pro3dure.com
  • Phone: 1 952 4261928
  • FAX: 1 952 6817515
  • Importer Type: Retailer
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Am Burgberg 13 ; Iserlohn Nordrhein-Westfalen, 58642 DE
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
GUDID EPRCD1000808 pro3dure medical GmbH	printodent GR-10 guide I MSI D1000808	2024-08-28
GUDID EPRC6575 pro3dure medical GmbH	IMPRIMO LC Splint comfort MSI 6575	2024-05-14
GUDID EPRC6550 pro3dure medical GmbH	IMPRIMO LC Splint comfort 6550	2024-05-14
GUDID EPRCD1001464 pro3dure medical GmbH	printodent GR-18.2 IB D1001464	2023-10-26
GUDID EPRCA4020230 pro3dure medical GmbH	audioprint L-2 FLX I MSI A4020230	2023-10-26
GUDID EPRCA4020229 pro3dure medical GmbH	audioprint L-2 FLX A4020229	2023-10-26
GUDID EPRCA1040441 pro3dure medical GmbH	audioprint L-1 I MSI A1040441	2023-10-26
GUDID EPRCA1040440 pro3dure medical GmbH	audioprint L-1 I MSI A1040440	2023-10-26
GUDID EPRCA1001520 pro3dure medical GmbH	audioprint GR-11.1 I MSI A1001520	2023-10-26
GUDID EPRCA1001516 pro3dure medical GmbH	audioprint GR-11.1 A1001516	2023-10-26
GUDID EPRCA1001515 pro3dure medical GmbH	audioprint GR-11.1 A1001515	2023-10-26
GUDID EPRCA1001514 pro3dure medical GmbH	audioprint GR-11.1 A1001514	2023-10-26
GUDID EPRCA1001513 pro3dure medical GmbH	audioprint GR-11.1 A1001513	2023-10-26
GUDID EPRCA1001512 pro3dure medical GmbH	audioprint GR-11.1 A1001512	2023-10-26
GUDID EPRCA1001511 pro3dure medical GmbH	audioprint GR-11.1 A1001511	2023-10-26
GUDID EPRCA1001510 pro3dure medical GmbH	audioprint GR-11.1 A1001510	2023-10-26
GUDID EPRCA0034302 pro3dure medical GmbH	otosil protect 50 I MSI A0034302	2023-10-26
GUDID EPRCA0034301 pro3dure medical GmbH	otosil protect 50 I MSI A0034301	2023-10-26
GUDID EPRCA0034300 pro3dure medical GmbH	otosil protect 50 I MSI A0034300	2023-10-26
GUDID EPRCA0034160 pro3dure medical GmbH	otosil SL-1 I MSI A0034160	2023-10-26
GUDID EPRCA0034151 pro3dure medical GmbH	otosil SL-1 A0034151	2023-10-26
GUDID EPRCA0034150 pro3dure medical GmbH	otosil SL-1 A0034150	2023-10-26
GUDID EPRCA0011000 pro3dure medical GmbH	otosil PS-1 A0011000	2023-10-26
GUDID EPRCA0010200 pro3dure medical GmbH	otosil IS-2 A0010200	2023-10-26
GUDID EPRCD1001653 pro3dure medical GmbH	printodent GR-21.1 Try-In D1001653	2023-10-24
GUDID EPRCD1001652 pro3dure medical GmbH	printodent GR-21.1 Try-In D1001652	2023-10-24
GUDID EPRCD1001651 pro3dure medical GmbH	printodent GR-21.1 Try-In D1001651	2023-10-24
GUDID EPRCA1000298 pro3dure medical GmbH	audioprint INR-1 A1000298	2023-10-24
GUDID EPRCA1000295 pro3dure medical GmbH	audioprint INR-1 A1000295	2023-10-24
GUDID EPRCA1000294 pro3dure medical GmbH	audioprint INR-1 A1000294	2023-10-24
GUDID EPRCD1001504 pro3dure medical GmbH	printodent GR-19.1 OA I MSI D1001504	2023-09-06
GUDID EPRCD1001501 pro3dure medical GmbH	printodent GR-19.1 OA D1001501	2023-09-06
GUDID EPRCD1001319 pro3dure medical GmbH	PRO3DURE GR-14.2 denture HI D1001319	2023-08-10
GUDID EPRCA4020141 pro3dure medical GmbH	Mixing Cannula A4020141	2023-03-08
GUDID EPRCA1001606 pro3dure medical GmbH	audioprint HPR-1 A1001606	2022-12-15
GUDID EPRCA1001605 pro3dure medical GmbH	audioprint HPR-1 A1001605	2022-12-15
GUDID EPRCA1001604 pro3dure medical GmbH	audioprint HPR-1 A1001604	2022-12-15
GUDID EPRCA1001603 pro3dure medical GmbH	audioprint HPR-1 A1001603	2022-12-15
GUDID EPRCA1001602 pro3dure medical GmbH	audioprint HPR-1 A1001602	2022-12-15
GUDID EPRCA1001601 pro3dure medical GmbH	audioprint HPR-1 A1001601	2022-12-15
GUDID EPRCA1001600 pro3dure medical GmbH	audioprint HPR-1 A1001600	2022-12-15
GUDID EPRCD1022006 pro3dure medical GmbH	PRO3DURE THERMEO Blank D1022006	2022-12-14
GUDID EPRCD1001611 pro3dure medical GmbH	PRO3DURE GR-19 OA D1001611	2022-12-14
GUDID EPRCD1001610 pro3dure medical GmbH	PRO3DURE GR-19 OA D1001610	2022-12-14
GUDID EPRCD1001609 pro3dure medical GmbH	PRO3DURE GR-19 OA D1001609	2022-12-14
GUDID EPRCD1001315 pro3dure medical GmbH	PRO3DURE GR-14.2 denture HI D1001315	2022-12-14
GUDID EPRCD1001301 pro3dure medical GmbH	PRO3DURE GR-14.1 denture D1001301	2022-12-14
GUDID EPRCD1001130 pro3dure medical GmbH	PRO3DURE GR-11 tray D1001130	2022-12-14
GUDID EPRCA4020147 pro3dure medical GmbH	PRO3DURE SysTherm PU A4020147	2022-12-14
GUDID EPRCA4020146 pro3dure medical GmbH	PRO3DURE SysTherm PU A4020146	2022-12-14
GUDID EPRCA4020145 pro3dure medical GmbH	PRO3DURE SysTherm PU A4020145	2022-12-14
GUDID EPRCA1040412 pro3dure medical GmbH	PRO3DURE L-1 A1040412	2022-12-14
GUDID EPRCA1040404 pro3dure medical GmbH	PRO3DURE L-1 A1040404	2022-12-14
GUDID EPRCA1040403 pro3dure medical GmbH	PRO3DURE L-1 A1040403	2022-12-14
GUDID EPRCA1040402 pro3dure medical GmbH	PRO3DURE L-1 A1040402	2022-12-14
GUDID EPRCA1040209 pro3dure medical GmbH	PRO3DURE L-1 A1040209	2022-12-14
GUDID EPRCA1040153 pro3dure medical GmbH	PRO3DURE L-1 A1040153	2022-12-14
GUDID EPRCA1000292 pro3dure medical GmbH	audioprint INR-1 A1000292	2022-12-14
GUDID EPRCA1000291 pro3dure medical GmbH	audioprint INR-1 A1000291	2022-12-14
GUDID EPRCA1000288 pro3dure medical GmbH	audioprint INR-1 A1000288	2022-12-14
GUDID EPRCA1000277 pro3dure medical GmbH	audioprint INR-1 A1000277	2022-12-14
GUDID EPRCA1000228 pro3dure medical GmbH	audioprint INR-1 A1000228	2022-12-14
GUDID EPRCA1000227 pro3dure medical GmbH	audioprint INR-1 A1000227	2022-12-14
GUDID EPRCA1000207 pro3dure medical GmbH	audioprint INR-1 A1000207	2022-12-14
GUDID EPRCA1000831 pro3dure medical GmbH	PRO3DURE GR-10 A1000831	2022-10-28
GUDID EPRCA1000827 pro3dure medical GmbH	PRO3DURE GR-10 A1000827	2022-10-28
GUDID EPRCA1000826 pro3dure medical GmbH	PRO3DURE GR-10 A1000826	2022-10-28
GUDID EPRCA1000825 pro3dure medical GmbH	PRO3DURE GR-10 A1000825	2022-10-28
GUDID EPRCA1000816 pro3dure medical GmbH	PRO3DURE GR-10 A1000816	2022-10-28
GUDID EPRCA1000815 pro3dure medical GmbH	PRO3DURE GR-10 A1000815	2022-10-28
GUDID EPRCA1000814 pro3dure medical GmbH	PRO3DURE GR-10 A1000814	2022-10-28
GUDID EPRCA1000813 pro3dure medical GmbH	PRO3DURE GR-10 A1000813	2022-10-28
GUDID EPRCA1000808 pro3dure medical GmbH	PRO3DURE GR-10 A1000808	2022-10-28
GUDID EPRCA1000806 pro3dure medical GmbH	PRO3DURE GR-10 A1000806	2022-10-28
GUDID EPRCA1000805 pro3dure medical GmbH	PRO3DURE GR-10 A1000805	2022-10-28
GUDID EPRCA1000770 pro3dure medical GmbH	PRO3DURE PR-1 A1000770	2022-10-28
GUDID EPRCA1000769 pro3dure medical GmbH	PRO3DURE PR-1 A1000769	2022-10-28
GUDID EPRCA1000768 pro3dure medical GmbH	PRO3DURE PR-1 A1000768	2022-10-28
GUDID EPRCA1000767 pro3dure medical GmbH	PRO3DURE PR-1 A1000767	2022-10-28
GUDID EPRCA1000766 pro3dure medical GmbH	PRO3DURE PR-1 A1000766	2022-10-28
GUDID EPRCA1000765 pro3dure medical GmbH	PRO3DURE PR-1 A1000765	2022-10-28
GUDID EPRCA1000764 pro3dure medical GmbH	PRO3DURE PR-1 A1000764	2022-10-28
GUDID EPRCA1000763 pro3dure medical GmbH	PRO3DURE PR-1 A1000763	2022-10-28
GUDID EPRCA1000762 pro3dure medical GmbH	PRO3DURE PR-1 A1000762	2022-10-28
GUDID EPRCA1000761 pro3dure medical GmbH	PRO3DURE PR-1 A1000761	2022-10-28
GUDID EPRCA1000760 pro3dure medical GmbH	PRO3DURE PR-1 A1000760	2022-10-28
GUDID EPRCA1000759 pro3dure medical GmbH	PRO3DURE PR-1 A1000759	2022-10-28
GUDID EPRCA1000758 pro3dure medical GmbH	PRO3DURE PR-1 A1000758	2022-10-28
GUDID EPRCA1000757 pro3dure medical GmbH	PRO3DURE PR-1 A1000757	2022-10-28
GUDID EPRCA1000756 pro3dure medical GmbH	PRO3DURE PR-1 A1000756	2022-10-28
GUDID EPRCA1000755 pro3dure medical GmbH	PRO3DURE PR-1 A1000755	2022-10-28
GUDID EPRCA1000754 pro3dure medical GmbH	PRO3DURE PR-1 A1000754	2022-10-28
GUDID EPRCA1000753 pro3dure medical GmbH	PRO3DURE PR-1 A1000753	2022-10-28
GUDID EPRCA1000752 pro3dure medical GmbH	PRO3DURE PR-1 A1000752	2022-10-28
GUDID EPRCA1000351 pro3dure medical GmbH	PRO3DURE GR-1 A1000351	2022-10-28
GUDID EPRCA1000338 pro3dure medical GmbH	PRO3DURE GR-1 A1000338	2022-10-28
GUDID EPRCA1000332 pro3dure medical GmbH	PRO3DURE GR-1 A1000332	2022-10-28
GUDID EPRCA1000331 pro3dure medical GmbH	PRO3DURE GR-1 A1000331	2022-10-28
GUDID EPRCA1000326 pro3dure medical GmbH	PRO3DURE GR-1 A1000326	2022-10-28
GUDID EPRCA1000307 pro3dure medical GmbH	PRO3DURE GR-1 A1000307	2022-10-28
PMN K212017 Pro3dure Medical GmbH	Thermeo System	2022-04-08
PMN K211415 Pro3dure Medical GmbH	GR Splint Resin System	2021-10-21
PMN K210298 Pro3dure Medical GmbH	GR-14 Resin System	2021-05-05
PMN K201827 Pro3dure Medical GmbH	GR-17 Resin System	2020-11-05
NDP PRO3DURE MEDICAL GMBH	GR-1 Guide;GR-10 Guide;STRUCTOMER SG	2019-02-28
ELK PRO3DURE MEDICAL GMBH	GR-17.1 Temporary Lt;STRUCTOMER TEMPS	2019-02-28
ELJ PRO3DURE MEDICAL GMBH	GR-17 Temporary	2019-02-28
EEA PRO3DURE MEDICAL GMBH	GR-21 Try-In	2019-02-28
EBH PRO3DURE MEDICAL GMBH	GR-11 Tray;GR-18.1 IB;STRUCTOMER IBT	2019-02-28
DYT PRO3DURE MEDICAL GMBH	GR-1 Guide;GR-10 Guide;GR-16 Xray;GR-19 OA;THERMEO;THERMEO Blank;Dima Print Splint Clear;STRUCTOMER SPLINT	2019-02-28
ESD PRO3DURE MEDICAL GMBH	GR-1;GR-10;L-1;PR-1;IN-R;Systherm	2019-02-12

Related Finance Registrations

NCAGE Code	CM225	PRO3DURE MEDICAL GMBH
CAGE Code	CM225	PRO3DURE MEDICAL GMBH