Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014888923

FEI Number

3014888923

Entity Name

PRO3DURE MEDICAL GMBH

City/State/Country

Iserlohn North Rhine-Westphalia, DE

Establishment Address

Am Burgberg 13, Iserlohn North Rhine-Westphalia 58642, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

pro3dure medical GmbH (Owner Number: 10059691)

Owner / Operator Contact Address

Am Burgberg 13, Iserlohn, DE-NW 58642, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

GR-16 x-ray GR-19.1 OA I MSI GR-19.1 OA Imprimo LC Splint comfort Imprimo LC Splint comfort MSI GR-21 Try-In GR-21.1 Try-In UCAN Print Try-In ACRY Print RU-003 Try-In otosil IS-1.1 Mixing Cannula for S50 System otosil IS-2 otosil PS-1 GR-11 Tray;GR-18.1 IB;STRUCTOMER IBT GR-16 Xray GR-18.2 IB UCAN Print Tray GR-11.1 Tray GR-1 Guide GR-17 temporary GR-17.1 temporary lt; Structomer Temps FLOW C&B ACRY Print RU-001 temporary GR-10 guide I MSI GR-19.1 OA UCAN Print Splint GR-19.1 OA I MSI BEGO PMMA Splint E THERMEO Liquid THERMEO SO Blank THERMEO Blank THERMEO Powder CORiTEC splint comfort GR-14.2 denture HI GR-14.1 denture UCAN Print Base ACRY Print RU-004 Denture HI FLOW Denture dima Print Denture Base 2 audioprint GR-1 audioprint GR-12.1 audioprint GR-11.1 I MSI otosil SL-1 I MSI SysTherm audioprint INR-1 audioprint HPR-1 audioprint GR-11 audioprint L-2 FLX I MSI audioprint L-1 audioprint GR-11.1 PR-1 otosil ES-1.1 audioprint L-2 FLX audioprint L-1 I MSI otosil protect 50 I MSI audioprint GR-10 otosil SL-1 SysTherm ECO

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DYT	Maintainer, Space Preformed, Orthodontic	Dental	Class 1	872.5525	2019-02-28
EEA	Plate, Base, Shellac	Dental	Class 1	872.6200	2019-02-28
LDG	Kit, Earmold, Impression	Ear, Nose, Throat	Class 1	874.3300	2022-03-07
EBH	Material, Impression Tray, Resin	Dental	Class 1	872.3670	2019-02-28
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2019-02-28
PZY	Additively Manufactured, Preformed, Resin Denture Tooth	Dental	Class 2	872.3590	2020-11-11
EBG	Crown And Bridge, Temporary, Resin	Dental	Class 2	872.3770	2020-11-11
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2024-08-12
KMY	Positioner, Tooth, Preformed	Dental	Class 1	872.5525	2024-08-12
MQC	Mouthguard, Prescription	Unknown	Class U	N/A	2022-04-12
EBI	Resin, Denture, Relining, Repairing, Rebasing	Dental	Class 2	872.3760	2021-05-06
ESD	Hearing Aid, Air-Conduction, Prescription	Ear, Nose, Throat	Class 1	874.3300	2019-02-12

Official Correspondent

Denis Gerasimov

US Agent Details

Scott Giller Email: scott.giller@pro3dure.com Phone: (952) 4261928

Related Public Records

Same Entity

pro3dure medical GmbH

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K800400	Dentsply Intl.	MAXUM DENTURE RESIN	1980-03-12
K033020	Cmp Industries, LLC	IMPAK ACRYLIC REPAIR RESIN LIQUID	2003-12-19
K892457	Telstar Electronics, Inc.	TELSTAR MODEL 1/3 ITE HEARING AID	1989-06-06
K760996	Unitron Industries, Inc.	HEARING AID (MODEL 695D, 905 & 960P)	1976-11-16
K840825	Maico Hearing Instruments, Inc.	SERIES MR IN-THE-EAR CUSTOM HEARING AID	1984-03-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0013-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	1	Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014888923. Last updated year: 2026. Please use registration number 3014888923 when referencing this establishment in official correspondence.