VSP System (Titanium Palatal Splint)
Device Facts
| Record ID | K261826 |
|---|---|
| Device Name | VSP System (Titanium Palatal Splint) |
| Applicant | 3D Systems, Inc. |
| Product Code | DZJ · Dental |
| Decision Date | Jun 3, 2026 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.4120 |
| Device Class | Class 2 |
| Attributes | 3rd-Party Reviewed |
Regulatory Classification
Identification
A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.
