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Sign in to claim this brandInstitut Straumann SA
US
Last updated May 23, 2026
What Institut Straumann SA makes
The company manufactures dental implant components, including permanent and temporary preformed suprastructures, two-piece screw endosteal implants, and custom-made ceramic crowns. It also produces metal-ceramic, ceramic, and polymer dental bridges, as well as abutments, bars, bridges, and temporary restorative discs for dental prosthetics.
These devices are regulated as Class I and Class II medical devices and are listed in the FDA’s Unique Device Identifier (UDI) database. The company is based 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 Institut Straumann SA primarily manufacture?
Institut Straumann SA specializes in dental implant components and restorative solutions. Their portfolio includes permanent and temporary preformed suprastructures for dental implants, two-piece screw endosteal implants, and custom-made ceramic crowns. They also produce dental bridges in metal-ceramic, ceramic, and polymer materials, as well as abutments, bars, bridges, and temporary restorative discs like PMMA (polymethyl methacrylate) discs for dental prosthetics. These devices are designed to support tooth replacement and restoration.
Where is Institut Straumann SA based, and how does this affect its regulatory oversight?
Institut Straumann SA is based in the United States. Since the company’s devices are regulated under U.S. medical device laws, their products must comply with FDA requirements, including classification as Class I or Class II devices. The FDA’s Unique Device Identifier (UDI) database lists their devices, ensuring traceability and transparency in the regulatory system. The U.S. location also means their products are subject to FDA premarket approvals, 510(k) clearances, or exemptions depending on the device class.
Which regulatory registries or databases list Institut Straumann SA’s devices?
Institut Straumann SA’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system assigns a unique product code to each device, enabling tracking, monitoring, and regulatory compliance. This database is a key resource for healthcare providers, regulators, and manufacturers to verify device details, including specifications, classifications, and manufacturing information.
How are Institut Straumann SA’s devices classified under U.S. regulations?
Institut Straumann SA’s devices are classified as either Class I or Class II medical devices under U.S. regulations. Class I devices generally pose minimal risk and may be exempt from premarket notification (510(k)) requirements, while Class II devices require special controls to ensure safety and effectiveness. The classification depends on factors like the device’s intended use, potential risks, and patient interaction—such as implants, bridges, and abutments—requiring higher scrutiny due to their direct contact with the body and functional importance in dental restoration.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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Catalogue (1819)
Page 10 of 37| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Straumann Dental Implant System | SLActive Roxolid TL | FDA UDI | Class II | Unknown |
| Pathfinder Nxt Minimally Invasive Pedicle Screw System | Bridges (implant borne) | FDA UDI | Class I | Unknown |
| Zerion Alpha, Zerion Beta | Bridges (tooth borne) | FDA UDI | Class II | Active |
| n!ce Zirconia | Milling Materials | FDA UDI | Class II | Unknown |
| Straumann Cares Bone Level Screw Retained Bars, Straumann Cares Bone Level Screw | 1 | FDA UDI | Class II | Unknown |
| Straumann P.004 Cementable Abutments, Temporary Copings And Protective Caps | Final Abutments | FDA UDI | Class II | Active |
| Pathfinder Nxt Minimally Invasive Pedicle Screw System | Bridges (implant borne) | FDA UDI | Class I | Unknown |
| Straumann Magellan Abutment, Protective Cap, Titanium - Gold Copings, Basal Screw | Final Abutments | FDA UDI | Class II | Active |
| Straumann TLX Implant System | SLActive Roxolid TL | FDA UDI | Class II | Unknown |
| Cementable Abuntments; Temporary Copings; Protective Caps | Final Abutments | FDA UDI | Class II | Active |
| n!ce Zirconia | Milling Materials | FDA UDI | Class II | Unknown |
| P.004 Abutments | Edentulous Abutments | FDA UDI | Class II | Active |
| Straumann Dental Implant System | SLActive Titanium BL | FDA UDI | Class II | Active |
| n!ce Zirconia | Milling Materials | FDA UDI | Class II | Unknown |
| Straumann TLX Novaloc and Cementable Abutments | Edentulous Abutments | FDA UDI | Class II | Active |
| n!ce Zirconia | Milling Materials | FDA UDI | Class II | Unknown |
| Straumann TLX Implant System | SLActive Roxolid TL | FDA UDI | Class II | Unknown |
| Straumann Magellan Abutment, Protective Cap, Titanium - Gold Copings, Basal Screw | Final Abutments | FDA UDI | Class II | Active |
| Straumann PURE Ceramic Implant System | Healing / Closure Screws | FDA UDI | Class II | Active |
| Straumann Dental Implant System | SLActive Roxolid BL | FDA UDI | Class II | Unknown |
| Straumann Modular Cassette | Storage Systems / Cassettes | FDA UDI | Class II | Active |
| Straumann Dental Implant System | SLActive Roxolid BL | FDA UDI | Class II | Active |
| KATANA Zirconia | Bridges (tooth borne) | FDA UDI | Class II | Active |
| KATANA Zirconia | Bridges (tooth borne) | FDA UDI | Class II | Unknown |
| Vitablocs | Crowns | FDA UDI | Class II | Unknown |
| Straumann TLX Implant System | SLA Roxolid TL | FDA UDI | Class II | Unknown |
| Straumann Variobase for Crown AS | Final Abutments | FDA UDI | Class II | Unknown |
| P.004 Abutments, Temporary Copings, Protective Caps, Permanent Copings | Final Copings | FDA UDI | Class II | Active |
| P.004 Abutments | Temporary Abutments | FDA UDI | Class II | Active |
| Modification To:straumann Guided Instruments | SLActive Titanium TL | FDA UDI | Class II | Unknown |
| Straumann Dental Implant System | SLActive Roxolid TL | FDA UDI | Class II | Unknown |
| CAD/CAM Abutments | 1 | FDA UDI | Class II | Unknown |
| P.004 Abutments, Temporary Copings, Protective Caps, Permanent Copings | Final Copings | FDA UDI | Class II | Unknown |
| Straumann Dental Implant System | SLActive Roxolid TL | FDA UDI | Class II | Unknown |
| Narrow Connection Straumann Anatomic Ips E.max Abutments | Final Abutments | FDA UDI | Class II | Active |
| Straumann Cares Variobase Abutment Nnc, Abutment Rn, Abutment Wn, Abutment | 1 | FDA UDI | Class II | Unknown |
| Straumann Narrow Neck Crossfit (nnc) 03.3mm Dental Implant System | Healing / Closure Screws | FDA UDI | Class II | Unknown |
| CAD/CAM Abutments | 1 | FDA UDI | Class II | Unknown |
| Straumann Bone Level NC Angled Screw Retained Abutments | Final Abutments | FDA UDI | Class II | Active |
| Pathfinder Nxt Minimally Invasive Pedicle Screw System | Bridges (implant borne) | FDA UDI | Class I | Unknown |
| Modification To:straumann Guided Instruments | SLActive Roxolid TL | FDA UDI | Class II | Active |
| Vita CAD-Temp For Inlab | Bridges (tooth borne) | FDA UDI | Class II | Active |
| N!CE Glass Ceramic Blocks For Amann Girrbach | Milling Materials | FDA UDI | Class II | Active |
| n!ce Zirconia | Milling Materials | FDA UDI | Class II | Unknown |
| ITI Dental Implant System | SLA Titanium TL | FDA UDI | Class II | Active |
| Straumann Modified Dental Abutment | Final Abutments | FDA UDI | Class II | Active |
| Straumann® Dental Implant System Roxolid® SLA Impl. | SLA Roxolid TL | FDA UDI | Class II | Active |
| Straumann Modular Cassette | Storage Systems / Cassettes | FDA UDI | Class II | Active |
| Straumann Dental Implant System | SLActive Titanium TL | FDA UDI | Class II | Active |
| n!ce Zirconia | Milling Materials | FDA UDI | Class II | Unknown |
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