FDA 510(k) Applications for Medical Device Product Code "DZJ"
(Driver, Wire, And Bone Drill, Manual)

FDA 510(k) Number Applicant Device Name Decision Date
K220366 3D LifePrints UK Ltd. EmbedMed 09/30/2022
K192192 3D Systems VSP System 02/26/2020
K210347 3D Systems VSP System 04/26/2021
K201353 CenterMed, Inc. CenterMed Patient Matched Assisted Surgical Planning (ASP) System 06/28/2021
K193301 Dental Wings GmbH coDiagnostiX 06/21/2021
K181813 ImmersiveTouch ImmersiveView Surgical Plan (IVSP«) 06/09/2020
K182789 KLS-Martin L.P. KLS Martin Individual Patient Solutions (IPS) Planning System 03/11/2019
K181241 KLS-Martin L.P. KLS Martin Individual Patient Solutions (IPS) Planning System 09/13/2018
K223024 MedCAD MedCAD AccuPlan System 03/07/2023
K192282 MedCAD MedCAD« AccuPlan« System 10/29/2020
K120956 MEDICAL MODELING INC VSP SYSTEM 12/12/2012
K133907 MEDICAL MODELING INC. VSP SYSTEM 01/22/2014
K212570 OsteoMed LLC OsteoPlan System 02/11/2022
K172164 Propel Orthodontics LLC PROPEL Device 01/17/2018
K150392 PROPEL ORTHODONTICS LLC. PROPEL device 09/18/2015
K193499 ProtoMED, Inc. DigiGuide System 11/04/2020
K040369 STRYKER INSTRUMENTS STRYKER CONSOLIDATED OPERATING ROOM EQUIPMENT (CORE) SYSTEM 04/01/2004
K150796 SYNTHES (USA) PRODUCTS, LLC Dental Bone Cutting Instruments 06/23/2015
K230276 TECHFIT Digital Surgery TECHFIT DISRP« System 06/23/2023
K231520 TechMah CMF tmCMF Solution 10/02/2023
K220648 VHA DEAN OMF ASP System 08/11/2022


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact