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Sign in to claim this brandSchütz Dental GmbH
US
Last updated May 23, 2026
What Schütz Dental GmbH makes
Schütz Dental GmbH manufactures dental materials for appliance fabrication, including ceramic and resin-based dentin and opaque materials, as well as dental composites and repair kits for ceramics. Their portfolio also includes polymer and metal-polymer dental bridges, dental casting alloys, and brazing alloys for dental applications.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. The company 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 dental devices does Schütz Dental GmbH manufacture?
Schütz Dental GmbH specializes in dental materials used for appliance fabrication and restorative procedures. Their product range includes ceramic and resin-based dentin and opaque materials for dental appliances, dental composites for fillings, repair kits for ceramic restorations, and dental bridges made from polymers, metal-polymer combinations, as well as casting and brazing alloys. These materials are designed to support dental technicians and practitioners in creating durable, functional, and aesthetically pleasing dental restorations.
Where is Schütz Dental GmbH based, and what does this mean for their regulatory oversight?
Schütz Dental GmbH is based in the United States. Since their devices are regulated under FDA jurisdiction, they must comply with U.S. medical device regulations, including classification under the FDA’s risk-based system. The company’s products fall under Class II, which typically requires premarket notification (510(k)) or other regulatory pathways to demonstrate substantial equivalence to a legally marketed predicate device before commercial distribution in the U.S.
Are Schütz Dental GmbH’s devices listed in any regulatory registries, and why does this matter?
Yes, Schütz Dental GmbH’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and transparency in the supply chain, allowing healthcare providers, regulators, and other stakeholders to quickly identify and verify the specific devices in use. Listing in the UDI database is mandatory for Class II devices in the U.S. and helps streamline recalls, post-market surveillance, and compliance efforts.
How are Schütz Dental GmbH’s dental devices classified under FDA regulations, and what does this classification imply?
All of Schütz Dental GmbH’s listed devices are classified as Class II under FDA regulations. This classification indicates that while the devices pose a moderate risk, they require special controls beyond general controls (like good manufacturing practices) to ensure safety and effectiveness. For Class II devices, manufacturers typically submit a 510(k) premarket notification to demonstrate that their device is substantially equivalent to a legally marketed predicate device, ensuring it meets applicable performance standards and regulatory requirements.
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
- 315830349
Catalogue (396)
Page 3 of 8| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Tizian Ceramic Incisal S2 | 624719 | FDA UDI | Class II | Active |
| ReVeneer Base | 232210 | FDA UDI | Class II | Active |
| Tizian Ceramic Liner Neutral | 624790 | FDA UDI | Class II | Active |
| Tizian Ceramic Dentin A4 | 624767 | FDA UDI | Class II | Active |
| Tizian Ceramic Dentin B3 | 624770 | FDA UDI | Class II | Active |
| ReVeneer Primer | 232211 | FDA UDI | Class II | Active |
| Tizian Ceramic Opaque Dentin B2 | 624744 | FDA UDI | Class II | Active |
| FuturaSelf Pink Opaque | 650622 | FDA UDI | Class II | Active |
| Tizian Ceramic Opaque Dentin B1 | 624743 | FDA UDI | Class II | Active |
| FuturaPress LT Pink IV | 650126 | FDA UDI | Class II | Active |
| Tizian Blank NEM, 98 x 15 mm | 220102 | FDA UDI | Class II | Active |
| FuturaPress LT Pink | 650113 | FDA UDI | Class II | Active |
| FuturAcryl 2000 Liquid | 650561 | FDA UDI | Class II | Active |
| Tizian Ceramic Chroma CR-A | 624879 | FDA UDI | Class II | Active |
| CoCr laser welding wire | 687553 | FDA UDI | Class II | Active |
| FuturaGen Pink Set 500 | 650903 | FDA UDI | Class II | Active |
| Tizian Blank Titanium Grade 2, 98 x 10 mm | 624484 | FDA UDI | Class II | Active |
| FuturaGen Pink Opaquer Set 1000 | 650907 | FDA UDI | Class II | Active |
| ReVeneer Adhesive Set | 232205 | FDA UDI | Class II | Active |
| Tizian Ceramic Dentin A3 | 624724 | FDA UDI | Class II | Active |
| Tizian Ceramic Opaque Dentin C2 | 624748 | FDA UDI | Class II | Active |
| FuturaGen Orange | 650925 | FDA UDI | Class II | Active |
| FuturaPress HP Liquid | 650461 | FDA UDI | Class II | Active |
| Tizian Ceramic Opaquer A3 | 624703 | FDA UDI | Class II | Active |
| Tizian Ceramic Incisal S3 | 624720 | FDA UDI | Class II | Active |
| Tizian Ceramic Opaque Dentin C3 | 624681 | FDA UDI | Class II | Active |
| Capo Hybrid A 4, 5 g | 232023 | FDA UDI | Class II | Active |
| Tizian Blank Zirconia Reinforced Composite B2 | 220116 | FDA UDI | Class II | Active |
| NanoPaq Incisal white, 4 g | 234540 | FDA UDI | Class II | Active |
| FuturaPress LT Pink Opaque | 650122 | FDA UDI | Class II | Active |
| Tizian Ceramic Shoulder SM D | 624876 | FDA UDI | Class II | Active |
| FuturaGen Pink Transparent Set | 650901 | FDA UDI | Class II | Active |
| Tizian Blank Zirconia Reinforced Composite A4 | 220113 | FDA UDI | Class II | Active |
| FuturaGen Clear | 650924 | FDA UDI | Class II | Active |
| Tizian Ceramic Incisal S3 | 624761 | FDA UDI | Class II | Active |
| NanoPaq Flow A 2, 2 g | 234711 | FDA UDI | Class II | Active |
| NanoPaq Opakdentin A 2, 0.3 g | 234630 | FDA UDI | Class II | Active |
| Microlit Isi, 250 g | 622124 | FDA UDI | Class II | Active |
| Tizian Ceramic Opaque Dentin A2 | 624671 | FDA UDI | Class II | Active |
| Tizian Ceramic Opaquer A3.5 | 624704 | FDA UDI | Class II | Active |
| FuturaJet Pink Opaque | 650012 | FDA UDI | Class II | Active |
| NanoPaq B 2, 0.3 g | 234616 | FDA UDI | Class II | Active |
| Tizian Ceramic Opaquer Fluid LO | 624780 | FDA UDI | Class II | Active |
| FuturaSelf Pink Transparent veined | 650611 | FDA UDI | Class II | Active |
| FuturAcryl 2000 Pink Transparent | 650520 | FDA UDI | Class II | Active |
| FuturaJet Pink veined | 650014 | FDA UDI | Class II | Active |
| Capo Flow A 4, 2 g | 234305 | FDA UDI | Class II | Active |
| FuturaJet Clear | 650025 | FDA UDI | Class II | Active |
| FuturaPress N Clear | 650225 | FDA UDI | Class II | Active |
| Capo Slow Flow A 2, 2 g | 232062 | FDA UDI | Class II | Active |
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