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POLIDENT 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
LinkedIn
—
Facebook
—
Email
[email protected]
Phone
+38653304840
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
644778409

Catalogue (7942)

Page 23 of 159
DeviceModel / ReferenceRegistriesClassStatus
Ref-Line REF.N4L1
FDA UDI
Class IIUnknown
Primodent PRI.03G3
FDA UDI
Class IIActive
Ref-Line REF.R4ZB4
FDA UDI
Class IIActive
PMMA CAD/CAM Disc PMMAML.071
FDA UDI
Class IIUnknown
Primodent PRI.S5SB5
FDA UDI
Class IIActive
PMMA CAD/CAM disc PMMA.544
FDA UDI
Class IIActive
Primodent PRV.43B1
FDA UDI
Class IIActive
Primodent PRI.33Y2
FDA UDI
Class IIActive
Primodent PRI.T6SB2
FDA UDI
Class IIUnknown
Primodent PRV.37AB4
FDA UDI
Class IIUnknown
Primodent PRV.01A2
FDA UDI
Class IIUnknown
PMMA CAD/CAM disc PMMA.095
FDA UDI
Class IIActive
Ref-Line REF.R4ZA2
FDA UDI
Class IIActive
PMMA CAD/CAM Disc PMMA.011
FDA UDI
Class IIActive
Primodent PRV.T2SA4
FDA UDI
Class IIActive
Primodent PRV.L6A4
FDA UDI
Class IIActive
Primodent PRI.L8B2
FDA UDI
Class IIUnknown
Cross Linked 2 CL.33C2
FDA UDI
Class IIActive
Ref-Line REF.K4L1
FDA UDI
Class IIActive
Cross Linked 2 CL.41D4
FDA UDI
Class IIActive
Primodent PRI.02Y1
FDA UDI
Class IIActive
Cross Linked 2 CL.34ID4
FDA UDI
Class IIActive
Primodent PRV.02C4
FDA UDI
Class IIActive
Ref-Line REF.F6SC4
FDA UDI
Class IIActive
Primodent PRI.I4G1
FDA UDI
Class IIActive
Primodent PRV.T1SC3
FDA UDI
Class IIActive
Ref-Line REF.M6C3
FDA UDI
Class IIActive
Cross Linked 2 CL.43B4
FDA UDI
Class IIActive
Primodent PRI.S3SB1
FDA UDI
Class IIActive
Cross Linked 2 CL.T5ZA9
FDA UDI
Class IIActive
Ref-Line REF.Q3SA1
FDA UDI
Class IIUnknown
Ref-Line REF.Q3SC4
FDA UDI
Class IIUnknown
Cross Linked 2 CL.37A1
FDA UDI
Class IIUnknown
PMMA CAD/CAM disc PMMA.689
FDA UDI
Class IIActive
Cross Linked 2 CL.I4D3
FDA UDI
Class IIActive
Primodent PRI.38Y0
FDA UDI
Class IIUnknown
Cross Linked 2 CL.06D4
FDA UDI
Class IIUnknown
Primodent PRV.38C1
FDA UDI
Class IIUnknown
Primodent PRV.03A3
FDA UDI
Class IIActive
Ref-Line REF.W4D2
FDA UDI
Class IIActive
Ref-Line REF.K3A2
FDA UDI
Class IIActive
Primodent PRV.T4ZD3
FDA UDI
Class IIUnknown
Ref-Line REF.N4A4
FDA UDI
Class IIUnknown
Ref-Line REF.Q3SC3
FDA UDI
Class IIActive
Ref-Line REF.R6ZL3
FDA UDI
Class IIUnknown
Ref-Line REF.Q1SB3
FDA UDI
Class IIActive
Primodent PRI.41G1
FDA UDI
Class IIActive
Cross Linked 2 CL.I1D3
FDA UDI
Class IIActive
Primodent PRV.37C1
FDA UDI
Class IIActive
Ref-Line REF.F6ZA1
FDA UDI
Class IIActive

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