# Pro3Dure Medical GmbH

- Location (FDA's records): Iserlohn, DE
- FDA decisions: 6 (2020–2026): 6 510(k) clearances
- Names in FDA's records: Pro3Dure Medical GmbH (5); Pro3Dure Medical (1)
- Product codes: MQC (4), EBI (1), EBG (1)
- 510(k) review time since 2016: median 168 days, against 158 for FDA's reviews in the same codes and years (2 of 5 faster)
- Predicates its devices cite: 11 (2 its own); citations of its devices by later devices: 5 (2 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mycone Dental Supply Co. Inc. (Dba Keystone Industries): 2 (https://510kreport.com/company/mycone-dental-supply-co-dba-keystone-industries)
- Keystone Industries: 2 (https://510kreport.com/company/keystone-industries)
- Vertex-Dental B.V.: 1 (https://510kreport.com/company/vertex-dental)
- Dentca, Inc.: 1 (https://510kreport.com/company/dentca)
- Astron Dental Corp.: 1 (https://510kreport.com/company/astron-dental)
- New Stetic: 1 (https://510kreport.com/company/new-stetic)
- Deltamed GmbH: 1 (https://510kreport.com/company/deltamed)

## Firms that cite its devices most
- Prismatik Dentalcraft, Inc.: 1 (https://510kreport.com/company/prismatik-dentalcraft)
- Detax GmbH & Co. KG: 1 (https://510kreport.com/company/detax)
- Hangzhou SHINING3D Dental Technology Co., Ltd.: 1 (https://510kreport.com/company/hangzhou-shining3d-dental-technology)

## Its most-cited devices
- K211415: GR Splint Resin System (2021), cited by 2
- K210298: GR-14 Resin System (2021), cited by 1
- K212017: Thermeo System (2022), cited by 1
- K201827: GR-17 Resin System (2020), cited by 1

## Recent decisions
- K260031: Thermeo® I Msi (Sep 29, 2026)
- K231775: GR Resin System MSI (Aug 8, 2024)
- K212017: Thermeo System (Apr 8, 2022)
- K211415: GR Splint Resin System (Oct 21, 2021)
- K210298: GR-14 Resin System (May 5, 2021)
- K201827: GR-17 Resin System (Nov 5, 2020)

Source page: https://510kreport.com/company/pro3dure-medical