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Sign in to claim this brandSILMET LTD
US
Last updated May 23, 2026
What SILMET LTD makes
Silmet Ltd manufactures dental restorative materials, including composite resins (e.g., Spherodon variants), dental amalgam (e.g., ProCopper), glass ionomer cements (e.g., ProGlass Two LC), and dentine bonding agents (e.g., ProFil Flow). Their portfolio also includes dental cements (e.g., Nogama) and veneer materials (e.g., ProVeneer) designed for dental restorations and adhesives.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) pathway or listed under the Unique Device Identifier (UDI) system. The company’s products are registered 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 Silmet Ltd manufacture?
Silmet Ltd specializes in dental restorative materials, including dental composite resins like Spherodon variants, dental amalgam such as ProCopper, glass ionomer cements like ProGlass Two LC, and dentine bonding agents like ProFil Flow. Their portfolio also covers dental cements (e.g., Nogama) and veneer materials (e.g., ProVeneer), all designed for dental restorations and adhesives.
Where is Silmet Ltd based, and where are their devices authorised?
Silmet Ltd is based in the United States. Their devices are authorised for use in the US through regulatory pathways like the FDA’s 510(k) pre-market notification process or via listing under the Unique Device Identifier (UDI) system.
Which regulatory registries list Silmet Ltd’s devices?
Silmet Ltd’s devices are registered in the FDA’s 510(k) pre-market notification database and the Unique Device Identifier (UDI) system, ensuring they meet US regulatory requirements for dental restorative materials.
How are Silmet Ltd’s devices classified under FDA regulations?
Silmet Ltd’s devices fall under Class II classification in the FDA’s regulatory framework. This classification applies to dental restorative materials that pose moderate risk and require special controls beyond general controls to ensure safety and effectiveness.
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
- 600071344
Catalogue (264)
Page 6 of 6| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Nogama | O-111309 | EUDAMEDFDA UDI | Class II | Active |
| Spherodon + | O-130493 | EUDAMEDFDA UDI | Class II | Active |
| ProVeneer | 18PVA1 | FDA UDI | Class II | Active |
| ProVeneer | 18PVAST | FDA UDI | Class II | Active |
| ProFil Temp | 19T4X7 | FDA UDI | Class II | Active |
| Spherodon - M | O-120471 | EUDAMEDFDA UDI | Class II | Active |
| Spherodon - M | O-121461 | FDA UDI | Class II | Active |
| Spherodon - M | 120110 | FDA UDI | Class II | Active |
| Spherodon + | O-131473 | FDA UDI | Class II | Active |
| Spherodon M Econom | 120481 | FDA UDI | Class II | Active |
| Spherodon + | 139491 | FDA UDI | Class II | Active |
| Proglass Cements (one, Two Two Lc, Nine, Plus, Silver) | K101869 | FDA 510(k) | Class II | Active |
| Prolink Adhesives (prolink, Prolink Se) | K110403 | FDA 510(k) | Class II | Active |
| Profil Composites (profil, Profil Flow) | K103190 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Silmet Ltd. OR YEHUDA Tel Aviv · IL FEI 4108