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Sign in to claim this brand3D SYSTEMS, INC.
US
Last updated May 27, 2026
What 3D SYSTEMS, INC. makes
The company produces custom-made orthopaedic and craniofacial surgical guides designed for precise bone-cutting procedures, as well as reusable and single-use osteotomy guides and surgical implant templates. It also manufactures custom organ and bone anatomy models for preoperative planning and reusable surgical drill guides for guided orthopaedic surgery. Additionally, the portfolio includes radiation therapy bolus materials for dose enhancement in cancer treatment and software applications for medical image segmentation.
All listed devices fall under FDA Class II regulation, with most authorised through the 510(k) pathway and some via the De Novo classification. The products are registered in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance tracking. The company is headquartered in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does 3D Systems, Inc. primarily manufacture?
3D Systems, Inc. specialises in devices for surgical precision and preoperative planning. Its portfolio includes custom-made orthopaedic and craniofacial surgical guides, reusable and single-use osteotomy guides, and surgical implant templates. The company also produces custom organ and bone anatomy models for training or planning, reusable surgical drill guides, and radiation therapy bolus materials to enhance treatment effectiveness. Additionally, it offers software applications for medical image segmentation, which aids in visualising and preparing anatomical data for surgical procedures.
Where is 3D Systems, Inc. based, and how does its location impact its regulatory compliance?
3D Systems, Inc. is headquartered in the United States, which means its devices are subject to FDA regulations. Since the company’s products fall under FDA Class II classification, they undergo rigorous review processes like the 510(k) pathway or De Novo classification to ensure safety and effectiveness before authorisation. The FDA’s Unique Device Identifier (UDI) database also tracks these devices, ensuring compliance and traceability throughout their lifecycle.
Which regulatory registries or databases list 3D Systems, Inc.’s devices?
3D Systems, Inc.’s devices are registered in the FDA’s Unique Device Identifier (UDI) database, which is a centralised system for tracking medical devices authorised in the U.S. Additionally, many of its products are authorised through the FDA’s 510(k) pathway, meaning they are listed in the FDA’s 510(k) database. This registration ensures transparency and compliance with U.S. regulatory requirements.
How are 3D Systems, Inc.’s devices classified under FDA regulations, and why does this matter?
All of 3D Systems, Inc.’s listed devices fall under FDA Class II classification, which indicates they pose moderate risk and require special controls to ensure safety and effectiveness. This classification means the devices undergo pre-market review processes like the 510(k) pathway (demonstrating substantial equivalence to a predicate device) or De Novo classification (for novel low-to-moderate-risk devices). The classification ensures that these devices meet stringent regulatory standards before they are authorised for use.
What is the significance of the FDA’s Unique Device Identifier (UDI) for 3D Systems, Inc.’s products?
The FDA’s Unique Device Identifier (UDI) system assigns a distinct code to each device, including those from 3D Systems, Inc., to improve tracking, reduce medical errors, and enhance post-market surveillance. Since the company’s devices are listed in the UDI database, healthcare providers and regulators can quickly verify device details, trace recalls, and ensure compliance with FDA requirements. This system also supports better inventory management and patient safety by providing clear, unmistakable identification for each authorised product.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- 3dsystems.com
- —
- —
- [email protected]
- Phone
- 8446431001
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 085049749
Catalogue (182)
Page 1 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| VSP System, VSP Cranial | Perfected Full Skull Model | FDA UDI | Class II | Active |
| VSP Orthopedics | Autograft Tibia Template | FDA UDI | Class II | Active |
| VSP System | Intermediate Sandwich Surgical Splint | FDA UDI | Class II | Active |
| VSP System | Surgical Splint | FDA UDI | Class II | Active |
| Vantage PSI | Tibia Cutting Guide | FDA UDI | Class II | Active |
| Vantage PSI | Anatomical Model | FDA UDI | Class II | Active |
| VSP System | Maxilla/Mandible 2-Piece Model | FDA UDI | Class II | Active |
| VSP System | Reconstructed Maxilla/Mandible 1-Piece Model | FDA UDI | Class II | Active |
| VSP System, VSP Cranial | Graft Pre-Contouring Template | FDA UDI | Class II | Active |
| VSP System, VSP Cranial | Resection Guide | FDA UDI | Class II | Active |
| VSP Orthopedics | Patient Orthopedic Model | FDA UDI | Class II | Active |
| VSP System | Perfected Maxilla/Mandible 2-Piece Model | FDA UDI | Class II | Active |
| Salto Talaris Flat Cut Total Ankle System | Talus Cutting Guide | FDA UDI | Class II | Active |
| VSP Orthopedics | Allograft Tibia Drilling Guide | FDA UDI | Class II | Active |
| PROcedure Rehearsal Studio | 2.0.1. | FDA UDI | Class II | Active |
| VSP Orthopedics | Autograft Tibia Cutting Guide | FDA UDI | Class II | Active |
| VSP System | Rib Cutting Guide | FDA UDI | Class II | Active |
| VSP System | Reconstructed Maxilla/Mandible 2-Piece Model | FDA UDI | Class II | Active |
| VSP System, VSP Cranial | Full Skull Model | FDA UDI | Class II | Active |
| VSP System, VSP Cranial | Perfected Anatomical Model | FDA UDI | Class II | Active |
| VSP System, VSP Cranial | Resected Full Skull Model | FDA UDI | Class II | Active |
| VSP System, VSP Cranial | Drill Guide (2.3 mm & 2.7 mm Screws) | FDA UDI | Class II | Active |
| VSP Orthopedics | Autograft Femur Drilling Guide | FDA UDI | Class II | Active |
| VSP System | Repositioned Mandible Model | FDA UDI | Class II | Active |
| VSP System | Maxilla Model | FDA UDI | Class II | Active |
| VSP System | Fibula Cutting Guide | FDA UDI | Class II | Active |
| VSP System, VSP Cranial | Bone Osteotomy Guide | FDA UDI | Class II | Active |
| VSP System | Genioplasty Positioning Guide | FDA UDI | Class II | Active |
| VSP Orthopedics | Patient Femur Drilling Guide | FDA UDI | Class II | Active |
| VSP Orthopedics | Patient Pelvic Marking Guide | FDA UDI | Class II | Active |
| VSP System | Plate Bending Template | FDA UDI | Class II | Active |
| VSP Orthopedics | Resected Allograft Orthopedic Model | FDA UDI | Class II | Active |
| Cadence Chamfer Cut Total Ankle System | Talus Cutting Guide | FDA UDI | Class II | Active |
| VSP Orthopedics | Allograft Pelvic Marking Guide | FDA UDI | Class II | Active |
| VSP System | Mandible Marking Guide | FDA UDI | Class II | Active |
| VSP System, VSP Cranial | Metal Slot (35mm) | FDA UDI | Class II | Active |
| VSP System, VSP Cranial | Resected Anatomical Model | FDA UDI | Class II | Active |
| VSP System, VSP Cranial | Trauma Drilling Guide | FDA UDI | Class II | Active |
| Vantage 3D+ PSI | Tibia Cutting Guide | FDA UDI | Class II | Active |
| VSP Cranial | Cranial Cutting Guide | FDA UDI | Class II | Active |
| VSP System | Maxillofacial Positioning Guide | FDA UDI | Class II | Active |
| VSP Orthopedics | Patient Tibia Marking Guide | FDA UDI | Class II | Active |
| VSP Orthopedics | Autograft Pelvic Cutting Guide | FDA UDI | Class II | Active |
| VSP System | Mandible Model | FDA UDI | Class II | Active |
| Cadence Chamfer Cut Total Ankle System | Anatomical model | FDA UDI | Class II | Active |
| VSP System, VSP Cranial | Surgical Positioning Template | FDA UDI | Class II | Active |
| VSP Orthopedics | Allograft Femur Cutting Guide | FDA UDI | Class II | Active |
| VSP System, VSP Cranial | Metal Slot (45mm) | FDA UDI | Class II | Active |
| VSP System | Intermediate Surgical Splint | FDA UDI | Class II | Active |
| VSP System | Scapula Cutting Guide | FDA UDI | Class II | Active |
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