Is this your brand? Sign in to claim ownership.
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
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (1819)
Page 28 of 37| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Straumann Retentive System - Novaloc TiN Abutments | Edentulous Abutments | FDA UDI | Class II | Active |
| Modification To:straumann Guided Instruments | SLActive Titanium TL | FDA UDI | Class II | Unknown |
| Modification To Iti Dental Implant System | SLA Titanium TL | FDA UDI | Class II | Active |
| Straumann Dental Implant System | SLActive Titanium TL | FDA UDI | Class II | Active |
| Straumann Narrow Neck Crossfit (nnc) 03.3mm Dental Implant System | Healing / Closure Screws | FDA UDI | Class II | Active |
| CAD/CAM Abutments | 1 | FDA UDI | Class II | Unknown |
| Straumann Emdogain | Emdogain | FDA UDI | Class III | Active |
| Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs | Bridges (tooth borne) | FDA UDI | Class II | Active |
| PURE Ceramic Implants | Temporary Coping | FDA UDI | Class II | Active |
| Vitablocs | Inlays / Onlays | FDA UDI | Class II | Unknown |
| n!ce Zirconia | Milling Materials | FDA UDI | Class II | Unknown |
| Straumann Retentive System - Novaloc TiN Abutments | Edentulous Abutments | FDA UDI | Class II | Active |
| Straumann Cares Bridge; Straumann Cares Dolder Bar | Bars | FDA UDI | Class II | Unknown |
| CAD/CAM Abutments | 1 | FDA UDI | Class II | Unknown |
| Straumann Cares Screw-Retained Bridge Titanium, Dolder Bar Titanium | Bridges (implant borne) | FDA UDI | Class II | Active |
| Straumann Bone Level Tapered Implant | SLActive Roxolid BL | FDA UDI | Class II | Active |
| Straumann PrefGel | PrefGel | FDA UDI | U | Active |
| n!ce Zirconia | Milling Materials | FDA UDI | Class II | Unknown |
| CAD/CAM Abutments | 1 | FDA UDI | Class II | Unknown |
| CAD/CAM Abutments | 1 | FDA UDI | Class II | Unknown |
| Vitablocs | Inlays / Onlays | FDA UDI | Class II | Unknown |
| Straumann Surgical Motor Pro Set - 120V | Y1001949-STM | FDA UDI | Class I | Active |
| CAD/CAM Abutments | 1 | FDA UDI | Class II | Unknown |
| Straumann Cares Screw Retained Bars/Bridge | Bridges (implant borne) | FDA UDI | Class II | Active |
| Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs | Bridges (tooth borne) | FDA UDI | Class II | Active |
| n!ce Zirconia | Milling Materials | FDA UDI | Class II | Unknown |
| PURE Ceramic Implants | Temporary Coping | FDA UDI | Class II | Active |
| Straumann Cares Screw-Retained Bridge Titanium, Dolder Bar Titanium | Bridges (implant borne) | FDA UDI | Class II | Active |
| Straumann Retentive System - Novaloc TiN Abutments | Edentulous Abutments | FDA UDI | Class II | Active |
| Titanium Healing Caps | Healing / Closure Screws | FDA UDI | Class II | Active |
| PURE Ceramic Implants | Temporary Coping | FDA UDI | Class II | Active |
| Base metal alloy | Bridges (tooth borne) | FDA UDI | Class II | Active |
| Straumann Magellan(tm) Abutment, Protective Cap, Copings, Basal Screw | Final Abutments | FDA UDI | Class II | Active |
| Straumann Retentive System - Novaloc TiN Abutments | Edentulous Abutments | FDA UDI | Class II | Active |
| Modification To Iti Dental Implant System | SLA Titanium TL | 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 Cares Variobase Abutment Nnc, Abutment Rn, Abutment Wn, Abutment | 1 | FDA UDI | Class II | Unknown |
| Straumann Cares Screw Retained Bars/Bridge | Bridges (implant borne) | FDA UDI | Class II | Active |
| Modification To:straumann Guided Instruments | SLActive Titanium TL | FDA UDI | Class II | Unknown |
| Bonefit Implant System Accessories & Instruments | 1 | 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 |
| Bl, 04.1 Mm Rc, Slactive 8mm, Tizr And 10mm, 12, 14mm | SLActive Roxolid BL | FDA UDI | Class II | Active |
| Straumann Magellan(tm) Abutment, Protective Cap, Copings, Basal Screw | Final Abutments | FDA UDI | Class II | Active |
| Straumann Cares Bridge; Straumann Cares Dolder Bar | Bridges (implant borne) | FDA UDI | Class II | Unknown |
| Straumann BLX Line Extension - New Abutments | Edentulous Abutments | FDA UDI | Class II | Active |
| Straumann Cares Bone Level Screw Retained Bars, Straumann Cares Bone Level Screw | 1 | FDA UDI | Class II | Active |
| Modification To:straumann Guided Instruments | SLActive Roxolid TL | FDA UDI | Class II | Active |
| n!ce Zirconia | Milling Materials | FDA UDI | Class II | Unknown |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.