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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 6 of 37| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Straumann® PUREloc Abutments | Edentulous Abutments | FDA UDI | Class II | Active |
| Straumann Cares Variobase Abutment Nnc, Abutment Rn, Abutment Wn, Abutment | 1 | FDA UDI | Class II | Unknown |
| Modification To:straumann Guided Instruments | SLActive Roxolid TL | FDA UDI | Class II | Active |
| Straumann Cares Bridge; Straumann Cares Dolder Bar | Bridges (implant borne) | FDA UDI | Class II | Unknown |
| Zerion Alpha, Zerion Beta | Copings | FDA UDI | Class II | Active |
| Straumann Modular Cassette | Storage Systems / Cassettes | FDA UDI | Class II | Active |
| Narrow Neck Temporary Coping | Temporary Coping | FDA UDI | Class II | Active |
| Tl 04.1mm Rn, S, Slactive Tizr 6, 8, 10, 12, 14, 16mm Dental Implants | SLActive Roxolid TL | FDA UDI | Class II | Active |
| Modification To Iti Dental Implant System | SLA Titanium TL | FDA UDI | Class II | Active |
| ITI Dental Implant System | SLA Titanium TL | FDA UDI | Class II | Active |
| Modification To:straumann Guided Instruments | SLActive Roxolid TL | FDA UDI | Class II | Active |
| Straumann BLX Implant System | Final Abutments | FDA UDI | Class II | Unknown |
| n!ce Zirconia | Milling Materials | FDA UDI | Class II | Unknown |
| n!ce Zirconia | Milling Materials | FDA UDI | Class II | Unknown |
| Iti Dental Implant System | SLA Titanium TL | 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 |
| Straumann P.004 Cementable Abutments, Temporary Copings And Protective Caps | 1 | FDA UDI | Class II | Active |
| Straumann Cares Bone Level Screw Retained Bars / Bridges | Bridges (implant borne) | FDA UDI | Class II | Active |
| Abutment And Prosthetic Accessories To The Iti Dental Implant System | Final Abutments | FDA UDI | Class II | Active |
| Vita CAD-Temp For Inlab | Bridges (tooth borne) | FDA UDI | Class II | Active |
| Bonefit Implant System Accessories & Instruments | Final Abutments | FDA UDI | Class II | Active |
| n!ce Zirconia | Milling Materials | FDA UDI | Class II | Unknown |
| Vitablocs | Crowns | FDA UDI | Class II | Unknown |
| Base metal alloy | Bridges (tooth borne) | FDA UDI | Class II | Active |
| Straumann Variobase for Crown AS | Final Abutments | FDA UDI | Class II | Unknown |
| Straumann Extraoral Implant System | EO | FDA UDI | Class I | Active |
| Straumann Cares Bone Level Screw Retained Bars, Straumann Cares Bone Level Screw | Bridges (implant borne) | FDA UDI | Class II | Unknown |
| Straumann® PUREloc Abutments | Edentulous Abutments | FDA UDI | Class II | Active |
| n!ce Zirconia | Milling Materials | FDA UDI | Class II | Unknown |
| n!ce Zirconia | Milling Materials | FDA UDI | Class II | Unknown |
| n!ce Zirconia | Milling Materials | FDA UDI | Class II | Unknown |
| Straumann Dental Implant System | SLActive Titanium TL | FDA UDI | Class II | Unknown |
| Straumann Bone Level Tapered Implant | SLActive Roxolid BL | FDA UDI | Class II | Active |
| Straumann Guided Instruments | surgically Invasive Instruments | FDA UDI | Class I | Active |
| P.004 Abutments, Temporary Copings, Protective Caps, Permanent Copings | Final Abutments | FDA UDI | Class II | Active |
| Base metal alloy | Bridges (tooth borne) | FDA UDI | Class II | Active |
| CAD/CAM Abutments | 1 | FDA UDI | Class II | Unknown |
| Narrow Connection Straumann Anatomic Ips E.max Abutments | Final Abutments | FDA UDI | Class II | Active |
| Straumann Variobase for Crown AS | Final Abutments | FDA UDI | Class II | Unknown |
| Straumann Cares Screw-Retained Bridge Titanium, Dolder Bar Titanium | Bridges (implant borne) | FDA UDI | Class II | Active |
| Base metal alloy | Bridges (tooth borne) | FDA UDI | Class II | Active |
| Straumann Cares Screw Retained Bars/Bridge | Bridges (tooth borne) | FDA UDI | Class II | Active |
| Straumann® Dental Implant System Roxolid® SLA Impl. | SLA Roxolid TL | FDA UDI | Class II | Active |
| n!ce Zirconia | Milling Materials | FDA UDI | Class II | Unknown |
| CAD/CAM Abutments | 1 | FDA UDI | Class II | Unknown |
| n!ce Glass Ceramic Blocks | Milling Materials | FDA UDI | Class II | Active |
| Modification To:straumann Guided Instruments | SLActive Titanium TL | FDA UDI | Class II | Unknown |
| n!ce Zirconia | Milling Materials | FDA UDI | Class II | Unknown |
| JUVORA Dental Disc, Ceramill PEEK by JUVORA | Bridges (tooth borne) | FDA UDI | Class II | Active |
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