Manufacturer registered with FDA
3D Systems, Inc.
Littleton, CO, United States. Lists 1 dental device type with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 1
- Brands and models
- 6
- 510(k) clearances
- 32020–2026
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 2007–2026
Registered in 2 markets
Where regulators' registries name 3D Systems, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | 3D Systems, Inc. | 3 clearances | 2020–2026 | Below |
| Israel | AMAR | Manufacturer | 3D Systems,Inc | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What 3D Systems, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Manual Wire Driver and Bone DrillDZJ · Class 2 | Surgical drills & motors | Maker | Jaw in a DayVSP DistractionVSP OrthognathicsVSP ReconstructionVSP SystemVSP Trauma | 2013 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names 3D Systems, Inc. as the applicant, including filings under its other names.
Also lists devices cleared under other names
3D Systems, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Medical Modeling, Inc. (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 22 Jan 2014 | K133907 | VSP SYSTEM | Medical Modeling, Inc. | DZJ Manual Wire Driver and Bone Drill |
| 12 Dec 2012 | K120956 | VSP SYSTEM | Medical Modeling, Inc. | DZJ Manual Wire Driver and Bone Drill |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| MEDICAL MODELING - A 3D SYSTEMS COMPANYFDA reg. 1724955 | Littleton, CO, United States | Manufacturer |
Other names on FDA records
Medical Modeling - A 3D Systems Company
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9052197). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.