OMF ASP System
FDA 510(k) clearance K220648 · decided 2022-08-11
Clearance details
- K-number
- K220648
- Device name
- OMF ASP System
- Applicant
- Vha Dean
- Decision
- Substantially Equivalent
- Date received
- 2022-03-07
- Decision date
- 2022-08-11
- Days to decision
- 157 days
- Clearance type
- Traditional
- Product code
- DZJ
- Device class
- 2
- Regulation number
- 872.4120
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Washington, DC, US
- Third-party review
- No
- Expedited review
- No
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| MedCAD AccuPlan System (K223024) | Medcad | 2023-03-07 |
| EmbedMed (K220366) | 3D Lifeprints UK , Ltd. | 2022-09-30 |
| OsteoPlan System (K212570) | Osteomed, LLC | 2022-02-11 |
| CenterMed Patient Matched Assisted Surgical Planning (ASP) System (K201353) | Centermed, Inc. | 2021-06-28 |
| coDiagnostiX (K193301) | Dental Wings GmbH | 2021-06-21 |
| VSP System (K210347) | 3D Systems | 2021-04-26 |
| DigiGuide System (K193499) | Protomed, Inc. | 2020-11-04 |
Recalls involving this device
No recalls on record reference this clearance.