BEUDAMED
    FDA Registration Active 🇩🇪 Germany

    PRO3DURE MEDICAL GMBH

    Reg #: 3014888923 · FEI: 3014888923 · Expires 2026
    View on FDA
    Products
    11
    Proprietary Names
    64
    Establishment Types
    1
    Classifications
    11

    Registration Details

    Registration Name
    PRO3DURE MEDICAL GMBH
    Registration Number
    3014888923
    FEI Number
    3014888923
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Am Burgberg 13
    City
    Iserlohn North Rhine-Westphalia
    Country
    DE

    Regulatory Submissions

    510(k) Number
    K201827

    Owner / Operator

    Firm Name
    pro3dure medical GmbH
    Operator Number
    10059691
    Address
    Am Burgberg 13
    City
    Iserlohn
    State
    North Rhine-Westphalia
    Postal Code
    58642
    Country
    DE
    Correspondent
    Denis Gerasimov

    Products

    Device Name Product Code
    Maintainer, Space Preformed, Orthodontic DYT
    Plate, Base, Shellac EEA
    Kit, Earmold, Impression LDG
    Material, Impression Tray, Resin EBH
    Accessories, Implant, Dental, Endosseous NDP
    Additively Manufactured, Preformed, Resin Denture Tooth PZY
    Crown And Bridge, Temporary, Resin EBG
    Mouthguard, Prescription MQC
    Positioner, Tooth, Preformed KMY
    Resin, Denture, Relining, Repairing, Rebasing EBI
    Hearing Aid, Air-Conduction, Prescription ESD

    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 UCAN Print Splint 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 dima Print Splint clear GR-22 flex GR-19 OA STRUCTOMER SPLINT GR-10 guide GR-20 MJF FLOW Hard Splint ACRY Print RU-005 Guide

    Establishment Types

    Manufacture Medical Device