Question 1

What types of medical devices does Institut Straumann SA primarily manufacture?

Accepted Answer

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.

Question 2

Where is Institut Straumann SA based, and how does this affect its regulatory oversight?

Accepted Answer

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.

Question 3

Which regulatory registries or databases list Institut Straumann SA’s devices?

Accepted Answer

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.

Question 4

How are Institut Straumann SA’s devices classified under U.S. regulations?

Accepted Answer

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.

Device	Model / Reference	Registries	Class	Status
Straumann Dental Implant System	Healing / Closure Screws	FDA UDI	Class II	Active
CAD/CAM Abutments	1	FDA UDI	Class II	Unknown
Modification To Iti Dental Implant System	SLA Titanium TL	FDA UDI	Class II	Active
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 P.004 Cementable Abutments, Temporary Copings And Protective Caps	Final Abutments	FDA UDI	Class II	Active
Bonefit Implant System Accessories & Instruments	Straumann Legacy	FDA UDI	Class II	Active
n!ce Zirconia	Milling Materials	FDA UDI	Class II	Unknown
CAD/CAM Abutments	1	FDA UDI	Class II	Unknown
Straumann TLX Implant System	SLActive Roxolid TL	FDA UDI	Class II	Unknown
Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs	Bridges (tooth borne)	FDA UDI	Class II	Active
Straumann Dental Implant System	SLActive Titanium TL	FDA UDI	Class II	Unknown
Straumann Magellan Abutment, Protective Cap, Titanium - Gold Copings, Basal Screw	Final Abutments	FDA UDI	Class II	Active
Straumann Extraoral Implant System	EO	FDA UDI	Class I	Unknown
CAD/CAM Abutments	1	FDA UDI	Class II	Unknown
P.004 Abutments, Temporary Copings, Protective Caps, Permanent Copings	1	FDA UDI	Class II	Active
n!ce Zirconia	Milling Materials	FDA UDI	Class II	Unknown
Pathfinder Nxt Minimally Invasive Pedicle Screw System	Bridges (implant borne)	FDA UDI	Class I	Active
n!ce Zirconia	Milling Materials	FDA UDI	Class II	Unknown
Straumann Modular Cassette	Storage Systems / Cassettes	FDA UDI	Class II	Active
CAD/CAM Abutments	1	FDA UDI	Class II	Unknown
Straumann Dental Implant System	SLActive Titanium BL	FDA UDI	Class II	Active
Pathfinder Nxt Minimally Invasive Pedicle Screw System	Bridges (implant borne)	FDA UDI	Class I	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
ITI Dental Implant System	SLA Titanium TL	FDA UDI	Class II	Unknown
n!ce Zirconia	Milling Materials	FDA UDI	Class II	Unknown
Straumann Cares Bridge; Straumann Cares Dolder Bar	Bridges (implant borne)	FDA UDI	Class II	Active
Straumann Cares Screw-Retained Bridge Titanium, Dolder Bar Titanium	Bridges (implant borne)	FDA UDI	Class II	Active
Abutment And Prosthetic Accessories To The Iti Dental Implant System	Final Copings	FDA UDI	Class II	Active
Straumann TLX Implant System	SLA Roxolid TL	FDA UDI	Class II	Unknown
CAD/CAM Abutments	1	FDA UDI	Class II	Unknown
JUVORA Dental Disc, Ceramill PEEK by JUVORA	Bridges (tooth borne)	FDA UDI	Class II	Active
Straumann TLX Novaloc and Cementable Abutments	Edentulous Abutments	FDA UDI	Class II	Active
Straumann Cares Variobase Abutment Nnc, Abutment Rn, Abutment Wn, Abutment	1	FDA UDI	Class II	Unknown
Straumann Retentive System - Novaloc TiN Abutments	Edentulous Abutments	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
Straumann RidgeFit Implants	Mini Implants	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® Variobase® Abutments and Straumann® n!ce® Zirconia discs	Bridges (tooth borne)	FDA UDI	Class II	Active
Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs	Bridges (tooth borne)	FDA UDI	Class II	Active
Straumann® Dental Implant System Roxolid® SLA Impl.	SLA Roxolid TL	FDA UDI	Class II	Active
P.004 Abutments, Temporary Copings, Protective Caps, Permanent Copings	1	FDA UDI	Class II	Active
Vitablocs	Inlays / Onlays	FDA UDI	Class II	Unknown
KATANA Zirconia	Bridges (tooth borne)	FDA UDI	Class II	Active
Pathfinder Nxt Minimally Invasive Pedicle Screw System	Bridges (implant borne)	FDA UDI	Class I	Active

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