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Sign in to claim this brandPOLIDENT d.o.o.
US
Last updated May 26, 2026
What POLIDENT d.o.o. makes
Polident produces resin-based dental prosthetics, including artificial teeth for partial and full dentures, temporary crowns and bridges, and custom-made polymer crowns. Their portfolio also includes materials for fabricating dental appliances, such as CAD/CAM discs and cross-linked PMMA resin systems.
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 medical devices does Polident d.o.o. manufacture?
Polident d.o.o. specializes in resin-based dental devices. Their primary products include artificial teeth for partial and full dentures, temporary dental crowns and bridges, custom-made polymer dental crowns, and materials used for fabricating dental appliances. These devices are designed to restore or replace missing or damaged teeth and structures in the mouth.
Where is Polident d.o.o. based, and how does that affect their regulatory standing?
Polident d.o.o. is based in the United States. Since their devices are regulated under U.S. jurisdiction, they must comply with FDA requirements. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, which helps track and monitor medical devices for safety and performance. The U.S. location also means their devices are subject to FDA classification and regulatory pathways specific to the American market.
Which regulatory registries or databases list Polident’s devices?
Polident’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system is a standardized approach to identifying medical devices, ensuring traceability and transparency in the regulatory process. Listing in this database helps healthcare providers, regulators, and manufacturers track specific devices like their resin artificial teeth, temporary crowns, and CAD/CAM materials.
How are Polident’s dental devices classified under FDA regulations?
Polident’s dental devices are classified as Class II under FDA regulations. This classification applies to devices that generally pose moderate risk and require special controls beyond general controls to ensure their safety and effectiveness. For example, resin artificial teeth and temporary crowns fall into this category because they require validation of material compatibility, fit, and functional performance to minimize risks like allergic reactions or improper fit.
What kinds of dental prosthetics does Polident focus on, and why are they considered Class II?
Polident focuses on resin-based dental prosthetics, including artificial teeth for dentures, temporary crowns/bridges, custom polymer crowns, and CAD/CAM fabrication materials. These devices are classified as Class II because they are not invasive but still require validation to ensure they meet performance standards—such as durability, biocompatibility, and proper fit—to prevent complications like irritation, infection, or structural failure. The FDA imposes additional controls (e.g., testing protocols) to mitigate these risks.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- polident.si
- —
- —
- [email protected]
- Phone
- +38653304840
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 644778409
Catalogue (7942)
Page 37 of 159| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Ref-Line | REF.H3C4 | FDA UDI | Class II | Active |
| Ref-Line | REF.Q1SC4 | FDA UDI | Class II | Unknown |
| Cross Linked 2 | CL.33A9 | FDA UDI | Class II | Unknown |
| PMMA CAD/CAM disc | PMMAML.975 | FDA UDI | Class II | Active |
| Cross Linked 2 | CL.T6ZA2 | FDA UDI | Class II | Unknown |
| PMMA CAD/CAM Disc | PMMA.537 | FDA UDI | Class II | Unknown |
| Cross Linked 2 | CL.06A9 | FDA UDI | Class II | Unknown |
| Primodent | PRI.41B4 | FDA UDI | Class II | Unknown |
| Primodent | PRI.05AY6 | FDA UDI | Class II | Active |
| Primodent | PRV.T2SB2 | FDA UDI | Class II | Active |
| PMMA CAD/CAM disc | PMMAML.331 | FDA UDI | Class II | Active |
| Cross Linked 2 | CL.T4ZC3 | FDA UDI | Class II | Unknown |
| Primodent | PRI.I5G6 | FDA UDI | Class II | Unknown |
| Ref-Line | REF.F2SC3 | FDA UDI | Class II | Unknown |
| Primodent | PRV.05AA4 | FDA UDI | Class II | Active |
| Ref-Line | REF.V6A1 | FDA UDI | Class II | Active |
| Cross Linked 2 | CL.41B4 | FDA UDI | Class II | Active |
| Primodent | PRV.S5ZA9 | FDA UDI | Class II | Unknown |
| Primodent | PRI.I7Y0 | FDA UDI | Class II | Active |
| Primodent | PRI.T3ZG5 | FDA UDI | Class II | Active |
| PMMA CAD/CAM disc | PMMAML.962 | FDA UDI | Class II | Active |
| PMMA CAD/CAM Disc | PMMA.019 | FDA UDI | Class II | Active |
| Primodent | PRV.I3A4 | FDA UDI | Class II | Unknown |
| PMMA CAD/CAM disc | PMMA.771 | FDA UDI | Class II | Active |
| PMMA CAD/CAM disc | PMMA.690 | FDA UDI | Class II | Active |
| Primodent | PRI.03G4 | FDA UDI | Class II | Active |
| Primodent | PRI.T3SG6 | FDA UDI | Class II | Unknown |
| Ref-Line | REF.V1B1 | FDA UDI | Class II | Active |
| PMMA CAD/CAM Disc | PMMA.240 | FDA UDI | Class II | Active |
| Primodent | PRV.T3SC4 | FDA UDI | Class II | Active |
| Cross Linked 2 | CL.T6SA1 | FDA UDI | Class II | Unknown |
| Ref-Line | REF.R4ZD4 | FDA UDI | Class II | Active |
| Ref-Line | REF.F4ZB3 | FDA UDI | Class II | Unknown |
| Primodent | PRV.04C1 | FDA UDI | Class II | Unknown |
| Cross Linked 2 | CL.T3ZC4 | FDA UDI | Class II | Unknown |
| Primodent | PRV.T1ZA9 | FDA UDI | Class II | Active |
| Primodent | PRI.I1B5 | FDA UDI | Class II | Active |
| Ref-Line | REF.N4B3 | FDA UDI | Class II | Active |
| Ref-Line | REF.N3D2 | FDA UDI | Class II | Active |
| Ref-Line | REF.M6A3 | FDA UDI | Class II | Active |
| DD poly Y ML | KML20716 | FDA UDI | Class II | Active |
| PMMA CAD/CAM Disc | PMMAML.461 | FDA UDI | Class II | Unknown |
| Ref-Line | REF.V8B2 | FDA UDI | Class II | Active |
| Primodent | PRV.31L3 | FDA UDI | Class II | Unknown |
| Primodent | PRV.38C3 | FDA UDI | Class II | Unknown |
| Ref-Line | REF.K3A3 | FDA UDI | Class II | Active |
| Primodent | PRV.I4A1 | FDA UDI | Class II | Active |
| PMMA CAD/CAM disc | PMMA.333 | FDA UDI | Class II | Active |
| Primodent | PRV.I1A4 | FDA UDI | Class II | Active |
| Cross Linked 2 | CL.03C3 | FDA UDI | Class II | Active |
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