VSP SYSTEM
FDA 510(k) clearance K120956 · decided 2012-12-12
Clearance details
- K-number
- K120956
- Device name
- VSP SYSTEM
- Applicant
- Medical Modeling, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2012-03-30
- Decision date
- 2012-12-12
- Days to decision
- 257 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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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| VSP System (Titanium Palatal Splint) (K261826) | 3D Systems, Inc. | 2026-06-03 |
| Materialise Personalized Guides and Models for Craniomaxillofacial Surgery (K243637) | Materialise NV | 2025-02-21 |
| TECHFIT DISRP® System (K242263) | Techfit Digital Surgery, Inc. | 2024-12-11 |
| tmCMF Solution (K231520) | Techmah Cmf | 2023-10-02 |
| TECHFIT DISRP® System (K230276) | Techfit Digital Surgery | 2023-06-23 |
| MedCAD AccuPlan System (K223024) | Medcad | 2023-03-07 |
| EmbedMed (K220366) | 3D Lifeprints UK , Ltd. | 2022-09-30 |
| OMF ASP System (K220648) | Vha Dean | 2022-08-11 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.