FDA.reportPublic FDA data

510(k) K223024

Device
MedCAD AccuPlan System
Applicant
Medcad
510(k) number
K223024
Product code
DZJ
Decision
Substantially Equivalent (SESE)
Decision date
2023-03-07
Date received
2022-09-29
Regulation
872.4120
Classification name
Driver, Wire, And Bone Drill, Manual
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Brian Buss
Address
501 S 2nd Ave. Suite A-1000 Dallas TX US 75226 75226

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DZJ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K243637Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryMaterialise NV2025-02-21
K242263TECHFIT DISRP® SystemTechfit Digital Surgery, Inc.2024-12-11
K231520tmCMF SolutionTechmah Cmf2023-10-02
K230276TECHFIT DISRP® SystemTechfit Digital Surgery2023-06-23
K220366EmbedMed3D Lifeprints UK , Ltd.2022-09-30
K220648OMF ASP SystemVha Dean2022-08-11
K212570OsteoPlan SystemOsteomed, LLC2022-02-11
K201353CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemCentermed, Inc.2021-06-28
K193301coDiagnostiXDental Wings GmbH2021-06-21
K210347VSP System3D Systems2021-04-26
K193499DigiGuide SystemProtomed, Inc.2020-11-04
K192282MedCAD® AccuPlan® SystemMedcad2020-10-29
K181813ImmersiveView Surgical Plan (IVSP®)Immersivetouch2020-06-09
K192192VSP System3D Systems2020-02-26
K182789KLS Martin Individual Patient Solutions (IPS) Planning SystemKLS-Martin L.P.2019-03-11