VSP System Resected Mandible Model
VSP System Resected Mandible Model is a custom-made organ/bone anatomy model (FDA Class II) made by 3D Systems, Inc., cleared under FDA 510(k) K210347 on 26 Apr 2021 (3 earlier submissions) and listed in FDA GUDID since 12 Sep 2016 (UDI-DI 00816847021258), active as of 22 Oct 2026. One FDA recall is linked to it.
Active
510(k)
Valid until
No expiry
FDA recalls
1 ongoingDocuments
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK210347 | Date26 Apr 2021 | StatusActive |
| United States | GUDID listing | Number00816847021258 | Date12 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 00816847021258
- FDA 510(k) database K210347
- FDA 510(k) database K192192
- FDA 510(k) database K133907
- FDA 510(k) database K120956
Across registries
- FDA 510(k) K210347 decided 26 Apr 2021 Active
- FDA GUDID UDI-DI 00816847021258 listed 12 Sep 2016 Listed
Recalls
-
- Ongoing Z-1510-2022
Scapula Marking Guide (anatomically Shaped) was incorrectly designed.
Timeline
- Cleared FDA 510(k) K120956
- Cleared FDA 510(k) K133907
- Listed FDA GUDID 00816847021258
- Cleared FDA 510(k) K192192
- Cleared FDA 510(k) K210347
- Recall initiated FDA recalls Z-1510-2022
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- VSP System
- Generic name
- Custom-made organ/bone anatomy model
- Model / reference
- Resected Mandible Model
- Primary DI / UDI-DI
- 00816847021258
- FDA product code
- LLZ, DZJ
- GMDN term
- Custom-made organ/bone anatomy model
- Device class
- Class II
- Regulation number
- 892.2050, 872.4120
- GUDID distribution status
- In Commercial Distribution
- Sterilisation method
- Moist Heat or Steam Sterilization
- MRI safety
- MR Unsafe