Medical Device Manufacturer · DE , Iserlohn

Pro3dure Medical GmbH - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 2020

Recent clearances: THERMEO® I MSI, Thermeo System, GR Splint Resin System

View 5 510(k) Devices ↓
5
Total
5
Cleared
0
Denied

FDA 510(k) Regulatory Record - Pro3dure Medical GmbH Dental ✕

5 devices
1-5 of 5
Cleared Sep 29, 2026
THERMEO® I MSI
K260031 · MQC
Dental · 266d
Cleared Apr 08, 2022
Thermeo System
K212017 · MQC
Dental · 284d
Cleared Oct 21, 2021
GR Splint Resin System
K211415 · MQC
Dental · 168d
Cleared May 05, 2021
GR-14 Resin System
K210298 · EBI
Dental · 91d
Cleared Nov 05, 2020
GR-17 Resin System
K201827 · EBG
Dental · 126d
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