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Sign in to claim this brandS & S Scheftner GmbH
US
Last updated May 23, 2026
What S & S Scheftner GmbH makes
S & S Scheftner GmbH manufactures dental casting alloys, including non-noble alloys used for dental restorations. Their portfolio includes products like Starbond Ti4, Starbond CoS, and Modelstar S, which are designed for dental casting applications, as well as materials for additive manufacturing in dentistry, such as Fusion AM. Additional offerings include casting alloys like Starbond Ni and MoguCera C, as well as dental casting systems like I-promelt and Modelstar S.
The company’s dental casting alloys are classified as Class II medical devices under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. These products are intended for use in dental laboratories and clinical settings for fabricating dental prosthetics and restorations. The manufacturer operates from 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 S & S Scheftner GmbH primarily manufacture?
S & S Scheftner GmbH specializes in dental casting alloys, with a focus on non-noble alloys. These materials are used to create dental restorations, such as crowns, bridges, and other prosthetics. Their portfolio includes products like Starbond Ti4, Starbond CoS, and Modelstar S, which are designed for dental casting applications, as well as materials like Fusion AM for additive manufacturing in dentistry. The company’s devices are tailored for dental laboratories and clinical settings.
Where is S & S Scheftner GmbH based, and how does that affect its regulatory standing?
S & S Scheftner GmbH is based in the United States. Since its devices fall under FDA jurisdiction, they are subject to U.S. medical device regulations. The company’s dental casting alloys, including products like Starbond Ni and MoguCera C, are classified as Class II devices, which requires compliance with FDA requirements for safety and performance. This classification is determined by the intended use and risk associated with the device.
Are S & S Scheftner GmbH’s devices listed in any regulatory registries, and why does this matter?
Yes, S & S Scheftner GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This listing ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and other stakeholders to identify and verify the devices. The UDI system helps streamline post-market surveillance, reporting, and compliance efforts, which is particularly important for Class II devices like those manufactured by the company.
How are S & S Scheftner GmbH’s dental casting alloys classified under FDA regulations?
S & S Scheftner GmbH’s dental casting alloys are classified as Class II medical devices under FDA regulations. This classification is based on the intended use of the products—such as fabricating dental restorations—and their associated risk level. Class II devices generally require special controls beyond general controls to ensure their safety and effectiveness, which may include performance standards, post-market surveillance, or labeling requirements.
What is the intended use of S & S Scheftner GmbH’s dental casting systems like Starbond Easy and I-promelt?
Devices like Starbond Easy and I-promelt are designed for dental casting systems, which are used in dental laboratories and clinical settings to create precise dental prosthetics and restorations. These systems involve melting and casting alloys to form custom-fit dental work, such as crowns or bridges. The classification as Class II reflects the need for controlled processes to ensure the materials meet safety and performance standards for patient use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 321810517
Catalogue (16)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Starbond Ti4 | 135715 | EUDAMEDFDA UDI | Class II | Active |
| Starbond CoS | 133000 | FDA UDI | Class II | Active |
| Modelstar S | 132100 | FDA UDI | Class II | Active |
| Starbond Easy | 140250 | FDA UDI | Class II | Active |
| Modelstar S | 132250 | FDA UDI | Class II | Active |
| Fusion AM | 137745 | FDA UDI | Class II | Active |
| Starbond Ni | 131000 | FDA UDI | Class II | Active |
| MoguCera C | 138000 | FDA UDI | Class II | Active |
| I-promelt | 39001010 | EUDAMEDFDA UDI | Class II | Active |
| Modelstar S | 132745 | FDA UDI | Class II | Active |
| Starbond Easy | 140745 | FDA UDI | Class II | Active |
| Starbond CoS | 133250 | FDA UDI | Class II | Active |
| MoguCera N | 139000 | FDA UDI | Class II | Active |
| Tipladur23 | 136720 | FDA UDI | Class II | Active |
| Starbond Co | 132000 | FDA UDI | Class II | Active |
| Starbond Easy | 140000 | FDA UDI | Class II | Active |
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