PROPEL Device
FDA 510(k) K172164 · Propel Orthodontics, LLC
510(k) numberK172164
Submission
- Device name
- PROPEL Device
- Applicant
- Propel Orthodontics, LLC
Milpitas, CA, US - Received
- July 18, 2017
- Decision date
- January 17, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K223024 | MedCAD AccuPlan SystemDZJ · Traditional | Medcad | 03/07/2023SE |
| K220366 | EmbedMedDZJ · Traditional | 3D Lifeprints UK , Ltd. | 09/30/2022SE |
| K220648 | OMF ASP SystemDZJ · Traditional | Vha Dean | 08/11/2022SE |
| K212570 | OsteoPlan SystemDZJ · Traditional | Osteomed, LLC | 02/11/2022SE |
| K201353 | CenterMed Patient Matched Assisted Surgical Planning (ASP) SystemDZJ · Traditional | Centermed, Inc. | 06/28/2021SE |
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Questions and answers
When was PROPEL Device cleared by the FDA?
PROPEL Device (K172164) received a 510(k) decision of Substantially Equivalent on January 17, 2018, 183 days after the submission was received.
What is the product code of K172164?
The FDA product code is DZJ – Driver, Wire, And Bone Drill, Manual, a Class II (moderate risk) device regulated under 21 CFR 872.4120.