OMF ASP System
FDA 510(k) K220648 · Vha Dean
510(k) numberK220648
Submission
- Device name
- OMF ASP System
- Applicant
- Vha Dean
Washington, DC, US - Received
- March 7, 2022
- Decision date
- August 11, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code DZJ
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|---|---|---|---|
| K261826 | VSP System (Titanium Palatal Splint)DZJ · Traditional | 3D Systems, Inc. | 06/03/2026SE |
| K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial SurgeryDZJ · Traditional | Materialise NV | 02/21/2025SE |
| K242263 | TECHFIT DISRP® SystemDZJ · Traditional | Techfit Digital Surgery, Inc. | 12/11/2024SE |
| K231520 | tmCMF SolutionDZJ · Traditional | Techmah Cmf | 10/02/2023SE |
| K230276 | TECHFIT DISRP® SystemDZJ · Traditional | Techfit Digital Surgery | 06/23/2023SE |
| K223024 | MedCAD AccuPlan SystemDZJ · Traditional | Medcad | 03/07/2023SE |
| K220366 | EmbedMedDZJ · Traditional | 3D Lifeprints UK , Ltd. | 09/30/2022SE |
| K212570 | OsteoPlan SystemDZJ · Traditional | Osteomed, LLC | 02/11/2022SE |
| K201353 | CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemDZJ · Traditional | Centermed, Inc. | 06/28/2021SE |
| K193301 | coDiagnostiXDZJ · Traditional | Dental Wings GmbH | 06/21/2021SE |
More from Dental Wings GmbH
| 510(k) | Device | Decision |
|---|---|---|
| K222639 | VHA Radiotherapy BolusIXI · Traditional | 11/04/2022SE |
Questions and answers
When was OMF ASP System cleared by the FDA?
OMF ASP System (K220648) received a 510(k) decision of Substantially Equivalent on August 11, 2022, 157 days after the submission was received.
What is the product code of K220648?
The FDA product code is DZJ – Driver, Wire, And Bone Drill, Manual, a Class II (moderate risk) device regulated under 21 CFR 872.4120.