FDA.reportPublic FDA data

510(k) K230276

Device
TECHFIT DISRP® System
Applicant
Techfit Digital Surgery
510(k) number
K230276
Product code
DZJ
Decision
Substantially Equivalent (SESE)
Decision date
2023-06-23
Date received
2023-02-01
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
Angela María Lema-Pérez
Address
1511 Aviation Center Pkwy. Suite 220h Daytona Beach FL US 32114 32114

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K193301coDiagnostiXDental Wings GmbH2021-06-21
K210347VSP System3D Systems2021-04-26
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K192282MedCAD® AccuPlan® SystemMedcad2020-10-29
K181813ImmersiveView Surgical Plan (IVSP®)Immersivetouch2020-06-09
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