TECHFIT DISRP® System

FDA 510(k) K242263 · Techfit Digital Surgery, Inc.

Substantially Equivalent

510(k) numberK242263

Submission

Device name
TECHFIT DISRP® System
Applicant
Techfit Digital Surgery, Inc.
Daytona Beach, FL, US
Received
August 1, 2024
Decision date
December 11, 2024
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DZJ – Driver, Wire, And Bone Drill, Manual
Device class
Class II (moderate risk)
Regulation
21 CFR 872.4120
Specialty
Dental

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K231520tmCMF SolutionDZJ · Traditional Techmah Cmf10/02/2023SE
K230276TECHFIT DISRP® SystemDZJ · Traditional Techfit Digital Surgery06/23/2023SE
K223024MedCAD AccuPlan SystemDZJ · Traditional Medcad03/07/2023SE
K220366EmbedMedDZJ · Traditional 3D Lifeprints UK , Ltd.09/30/2022SE
K220648OMF ASP SystemDZJ · Traditional Vha Dean08/11/2022SE
K212570OsteoPlan SystemDZJ · Traditional Osteomed, LLC02/11/2022SE
K201353CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemDZJ · Traditional Centermed, Inc.06/28/2021SE
K193301coDiagnostiXDZJ · Traditional Dental Wings GmbH06/21/2021SE

More from Dental Wings GmbH

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K250297TECHFIT Patient-Specific Cranial SystemGWO · Traditional 10/27/2025SE
K230276TECHFIT DISRP® SystemDZJ · Traditional 06/23/2023SE
K222577TECHFIT Diagnostic ModelsLLZ · Traditional 01/06/2023SE
K220199AFFINITY Proximal Tibia SystemHRS · Traditional 03/21/2022SE

Questions and answers

When was TECHFIT DISRP® System cleared by the FDA?

TECHFIT DISRP® System (K242263) received a 510(k) decision of Substantially Equivalent on December 11, 2024, 132 days after the submission was received.

What is the product code of K242263?

The FDA product code is DZJ – Driver, Wire, And Bone Drill, Manual, a Class II (moderate risk) device regulated under 21 CFR 872.4120.