Is this your brand? Sign in to claim ownership.
Sign in to claim this brandUNION DENTAL SA
US
Last updated May 23, 2026
What UNION DENTAL SA makes
Union Dental SA manufactures temporary dental crowns and bridges, as well as resin-based artificial teeth for dental prosthetics. Their product line includes polymethyl methacrylate (PMMA) resin systems for dental restorations, designed for short-term use in patient care.
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 within the United States regulatory framework for dental materials and restorative products.
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 Union Dental SA manufacture?
Union Dental SA specializes in temporary dental crowns and bridges, as well as resin artificial teeth for dental prosthetics. Their products include polymethyl methacrylate (PMMA) resin systems, which are primarily used for short-term dental restorations. These devices are designed to provide functional and aesthetic solutions during transitional phases of dental treatment.
Where is Union Dental SA based, and under which regulatory framework do their devices operate?
Union Dental SA is based in the United States. Their devices operate under the U.S. regulatory framework, specifically adhering to FDA guidelines. Since their products fall under Class II classification, they are subject to FDA requirements for moderate-risk medical devices, including registration, listing, and compliance with quality system regulations.
Are Union Dental SA’s devices listed in any regulatory registries, and if so, which ones?
Yes, Union Dental SA’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 identify and verify the devices through a standardized identification system.
How are Union Dental SA’s devices classified under FDA regulations?
Union Dental SA’s devices are classified as Class II under FDA regulations. This classification is assigned based on the level of control needed to ensure the device’s safety and effectiveness. Class II devices generally require special controls in addition to general controls (like good manufacturing practices) to mitigate potential risks, such as those associated with temporary restorations or resin-based dental materials.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- —
- —
- —
- —
- Phone
- —
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 462114760
Catalogue (3318)
Page 5 of 67| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Eledent | ANTERIOR TEETH D3/N5 | FDA UDI | Class II | Active |
| Ortolux Top | ANTERIOR TEETH 62/21 | FDA UDI | Class II | Active |
| 10temp | DISC BL3 5 LAYERS 98,5/16mm | EUDAMEDFDA UDI | Class II | Active |
| 10temp | DISC A3,5 5 LAYERS 95/16mm | EUDAMEDFDA UDI | Class II | Active |
| Ortolux Top | POSTERIOR TEETH B0/33LI | FDA UDI | Class II | Active |
| 10temp | DISC BL2 5 LAYERS 98,5/16mm | EUDAMEDFDA UDI | Class II | Active |
| Ortolux Top | ANTERIOR TEETH D4/2DD | FDA UDI | Class II | Active |
| Odipal | POSTERIOR TEETH A1/S6I | FDA UDI | Class II | Active |
| Anaxdent Pmma | U Monolayer BLANK BL4 98,5/25mm | FDA UDI | Class II | Active |
| 10temp | DISC B3 10 LAYERS 95/25mm | EUDAMEDFDA UDI | Class II | Active |
| Ortolux Top | ANTERIOR TEETH D3/3R | FDA UDI | Class II | Active |
| Eledent | ANTERIOR TEETH C2/C22 | FDA UDI | Class II | Active |
| Ortolux Top | ANTERIOR TEETH D4/3P | FDA UDI | Class II | Active |
| Odipal | POSTERIOR TEETH C2/M34S | FDA UDI | Class II | Active |
| Ortolux Top | ANTERIOR TEETH 59/4 | FDA UDI | Class II | Active |
| Anaxdent Pmma Blank | PMMA MULTI Blank Z B1 20mm | FDA UDI | Class II | Unknown |
| Ortolux Top | POSTERIOR TEETH 59/54S | FDA UDI | Class II | Active |
| Idodentine | DISC B2 MULTI 95/16mm | FDA UDI | Class II | Active |
| Ortolux Top | ANTERIOR TEETH 67/A25 | FDA UDI | Class II | Active |
| Eledent | POSTERIOR TEETH A3,5/32FS | FDA UDI | Class II | Active |
| Ortolux Top | POSTERIOR TEETH 59/29MZS | FDA UDI | Class II | Active |
| Ortolux Top | ANTERIOR TEETH 77/20 | FDA UDI | Class II | Active |
| Ortolux Top | POSTERIOR TEETH 59/33LS | FDA UDI | Class II | Active |
| Idodentine | DISC GREEN TRANSP 98,5/16mm | FDA UDI | Class II | Active |
| Odipal | POSTERIOR TEETH A3/M35I | FDA UDI | Class II | Active |
| Odipal | POSTERIOR TEETH B3/M41I | FDA UDI | Class II | Active |
| Eledent | ANTERIOR TEETH B3/N5 | FDA UDI | Class II | Active |
| Idodentine | DISC B4 98,5/25mm | FDA UDI | Class II | Active |
| Idodentine | BLOCK (3 UNITS) MULTI A3 - 15,5x19x39mm | FDA UDI | Class II | Active |
| Ortolux Top | ANTERIOR TEETH A4/2DD | FDA UDI | Class II | Active |
| Odipal | POSTERIOR TEETH B2/M34I | FDA UDI | Class II | Active |
| Odipal | ANTERIOR TEETH C2/78 | FDA UDI | Class II | Active |
| Odipal | ANTERIOR TEETH A4/U17 | FDA UDI | Class II | Active |
| Ortolux Top | POSTERIOR TEETH 68/54I | FDA UDI | Class II | Active |
| Ortolux Top | ANTERIOR TEETH B0/15 | FDA UDI | Class II | Active |
| Odipal | POSTERIOR TEETH 0/M35I | FDA UDI | Class II | Active |
| Odipal | ANTERIOR TEETH B4/50 | FDA UDI | Class II | Active |
| Idodentine | DISC BG3 98,5/20mm | FDA UDI | Class II | Active |
| Odipal | POSTERIOR TEETH B2/S6I | FDA UDI | Class II | Active |
| Odipal | ANTERIOR TEETH D2/U16 | FDA UDI | Class II | Active |
| Ortolux Top | ANTERIOR TEETH A2/1NN | FDA UDI | Class II | Active |
| Odipal | ANTERIOR TEETH C4/52 | FDA UDI | Class II | Active |
| Idodentine | DISC DARK PINK V6 (#51) 98,5/25mm | FDA UDI | Class II | Active |
| Odipal | POSTERIOR TEETH A1/M41S | FDA UDI | Class II | Active |
| Odipal | POSTERIOR TEETH A3,5/M34S | FDA UDI | Class II | Active |
| Odipal | POSTERIOR TEETH 0/M42I | FDA UDI | Class II | Active |
| Ortolux Top | POSTERIOR TEETH C2/29MZS | FDA UDI | Class II | Active |
| Ortolux Top | POSTERIOR TEETH A2/54I | FDA UDI | Class II | Active |
| Ortolux Top | ANTERIOR TEETH 69/2N | FDA UDI | Class II | Active |
| Odipal | POSTERIOR TEETH B1/M42S | FDA UDI | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.