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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 12 of 37| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Synocta Prosthetics | Final Copings | FDA UDI | Class II | Unknown |
| Straumann TLX Implant System | Final 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 |
| Straumann TLX Implant System | SLA Roxolid TL | FDA UDI | Class II | Unknown |
| Straumann TLX Implant System | SLA Roxolid TL | FDA UDI | Class II | Unknown |
| Straumann Retentive System - Novaloc TiN Abutments | Edentulous Abutments | FDA UDI | Class II | Active |
| Straumann Cares Bone Level Screw Retained Bars, Straumann Cares Bone Level Screw | Bridges (implant borne) | FDA UDI | Class II | Active |
| Straumann TLX Novaloc and Cementable Abutments | Edentulous Abutments | FDA UDI | Class II | Active |
| Straumann RidgeFit Implants | Mini Implants | FDA UDI | Class II | Active |
| Straumann Bone Level NC Angled Screw Retained Abutments | Final Abutments | FDA UDI | Class II | Active |
| Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs | Bridges (tooth borne) | FDA UDI | Class II | Active |
| Straumann TLX Implant System | Final Abutments | FDA UDI | Class II | Active |
| n!ce Zirconia | Milling Materials | FDA UDI | Class II | Unknown |
| Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs | Crowns | 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 |
| 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 |
| P.004 Healing Abutments And Closure Screws | Healing / Closure Screws | FDA UDI | Class II | Active |
| n!ce Glass Ceramic Blocks for Amann Girrbach | Milling Materials | FDA UDI | Class II | Active |
| P.004 Abutments, Temporary Copings, Protective Caps, Permanent Copings | Final Copings | FDA UDI | Class II | Active |
| Straumann Screw-Retained Abutments | Temporary Coping | FDA UDI | Class II | Active |
| Straumann Dental Implant System | SLActive Titanium TL | FDA UDI | Class II | Active |
| Base metal alloy | Bridges (tooth borne) | FDA UDI | Class II | Active |
| Straumann Variobase Abutment / IPS e.max CAD restorations | Bridges (tooth borne) | FDA UDI | Class II | Active |
| Pathfinder Nxt Minimally Invasive Pedicle Screw System | Bridges (implant borne) | FDA UDI | Class I | Unknown |
| Zenotec Zr Bridge, Zenostar Zr Translucent | 1 | FDA UDI | Class II | Unknown |
| P.004 Abutments, Temporary Copings, Protective Caps, Permanent Copings | Final Copings | FDA UDI | Class II | Active |
| Nnc Solid Abutment Nnc Temporary Coping For Colid Abutment Nnc Temporary Cap For | 1 | FDA UDI | Class I | Active |
| Straumann Retentive System - Novaloc TiN Abutments | Edentulous Abutments | FDA UDI | Class II | Active |
| 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 |
| n!ce Zirconia | Milling Materials | FDA UDI | Class II | Unknown |
| CAD/CAM Abutments | 1 | FDA UDI | Class II | Unknown |
| n!ce Zirconia | Milling Materials | FDA UDI | Class II | Unknown |
| Iti Transversal Screwing System | Screws | FDA UDI | Class II | Active |
| Straumann TLX Implant System | SLA Roxolid TL | FDA UDI | Class II | Unknown |
| Straumann Orthosystem | Palatal-System | FDA UDI | Class II | Active |
| JUVORA Dental Disc, Ceramill PEEK by JUVORA | Bridges (tooth borne) | FDA UDI | Class II | Active |
| n!ce Zirconia | Milling Materials | FDA UDI | Class II | Unknown |
| Straumann P.004 Cementable Abutments, Temporary Copings And Protective Caps | 1 | FDA UDI | Class II | Active |
| Straumann Cares Screw Retained Bars/Bridge | Bridges (implant borne) | FDA UDI | Class II | Active |
| Vita CAD-Temp For Inlab | Bridges (tooth borne) | FDA UDI | Class II | Active |
| Straumann TLX Implant System | SLActive Roxolid TL | FDA UDI | Class II | Unknown |
| Straumann Computer Aided Restoration Service (C.A.R.E.S.) Ceramic Coping | Screws | FDA UDI | Class II | Active |
| Straumann BLX Implant System | Final Abutments | FDA UDI | Class II | Unknown |
| Straumann TLX Implant System | SLA Roxolid TL | FDA UDI | Class II | Active |
| n!ce Glass Ceramic Blocks | Crowns | FDA UDI | Class II | Active |
| Straumann Boneceramic | BoneCeramic | FDA UDI | Class II | Active |
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