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Sign in to claim this brandOPA DENTAL, LLC
US
Last updated September 17, 2026
What OPA DENTAL, LLC makes
OPA Dental, LLC manufactures dental materials for crown and bridge fabrication, including ceramic-based appliance fabrication materials, temporary crowns and bridges, and dental composite resins. Their portfolio also includes single-use injection cannulas for dental materials and silicone-based impression materials for dental impressions.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identifier (UDI) database. OPA Dental, LLC is based 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 dental devices does OPA Dental, LLC manufacture?
OPA Dental, LLC specializes in dental materials used primarily for crown and bridge fabrication. Their product portfolio includes ceramic-based appliance fabrication materials, temporary dental crowns and bridges, dental composite resins, single-use injection cannulas for dental materials, and silicone-based impression materials for dental impressions. These materials are designed to support various stages of dental restoration procedures.
Where is OPA Dental, LLC based?
OPA Dental, LLC is headquartered in the United States. The company’s location is relevant for understanding its regulatory framework, as it operates under the jurisdiction of the U.S. Food and Drug Administration (FDA).
Which regulatory registries or databases list OPA Dental, LLC’s devices?
OPA Dental, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. The UDI system helps track and identify medical devices, ensuring transparency and traceability in the regulatory process. This listing is specific to individual devices, not the company itself.
How are OPA Dental, LLC’s devices classified by the FDA?
OPA Dental, LLC’s devices fall under FDA’s Class I and Class II classifications. Class I devices generally pose minimal risk and are subject to general controls, while Class II devices require additional performance standards due to moderate risk. The classification depends on factors like the device’s intended use and potential health impact, as outlined in FDA regulations.
What is the purpose of the dental materials produced by OPA Dental, LLC?
The dental materials produced by OPA Dental, LLC are designed for clinical applications in restorative dentistry. For example, ceramic-based materials are used for fabricating long-term dental appliances, while temporary crowns and bridges provide interim solutions during treatment planning. Composite resins and impression materials support precise fitting and durability in dental restorations, ensuring functional and aesthetic outcomes for patients.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- 105 Whitaker blvd, Huntington, WV, 25701
- 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
- 3008582406
- DUNS Number
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Catalogue (2293)
Page 27 of 46| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Luna-Orea | OREA9516MLA3 | FDA UDI | Class II | Active |
| Orea Plus | OREAPL9518C1 | FDA UDI | Class II | Active |
| Luna-Orea | OREA9518MLA35 | FDA UDI | Class II | Active |
| Iluzion | LZN4019C3 | FDA UDI | Class II | Active |
| Orea Plus | OREAPL9830D2 | FDA UDI | Class II | Active |
| Orea Plus | OREAPL9822C2 | FDA UDI | Class II | Active |
| Luna-Orea | OREA9812MLB4 | FDA UDI | Class II | Active |
| Orea Plus | OREAPL9520D3 | FDA UDI | Class II | Active |
| Luna | PMMA4019A4 | FDA UDI | Class II | Active |
| Iluzion | LZN6525D4 | FDA UDI | Class II | Active |
| Luna | LOD10025TC4 | FDA UDI | Class II | Active |
| Luna | LWD9816TB4 | FDA UDI | Class II | Active |
| Opa | OPAFILL4P2 | FDA UDI | Class II | Active |
| Iluzion | LZN9810 | FDA UDI | Class II | Active |
| Luna | LOD10010TA2 | FDA UDI | Class II | Active |
| Orea Plus | OREAPL9818D3 | FDA UDI | Class II | Active |
| Luna | LZ9525 | FDA UDI | Class II | Active |
| Luna | LWD9818TRB4 | FDA UDI | Class II | Active |
| Luna | LWD9822TD4 | FDA UDI | Class II | Active |
| Luna-Orea | OCL20C2 | FDA UDI | Class II | Active |
| Luna | LS4019TD2 | FDA UDI | Class II | Active |
| Luna-Orea | OREA9514MLA35 | FDA UDI | Class II | Active |
| Luna-Orea | OREA10022MLA2 | FDA UDI | Class II | Active |
| Luna | LZ9522 | FDA UDI | Class II | Active |
| Luna | LS2019TA1 | FDA UDI | Class II | Active |
| Luna | LWD9812TB3 | FDA UDI | Class II | Active |
| Luna | LOD10010TA35 | FDA UDI | Class II | Active |
| Luna-Orea | OREA10025MLD3 | FDA UDI | Class II | Active |
| Luna | LOD10020TB4 | FDA UDI | Class II | Active |
| Luna | LOD10025TD3 | FDA UDI | Class II | Active |
| Orea Plus | OREAPL9814B1 | FDA UDI | Class II | Active |
| Luna-Orea | OREA9816MLA2 | FDA UDI | Class II | Active |
| Luna-Orea | OREA9816RMLB3 | FDA UDI | Class II | Active |
| Luna-Orea | OREA9825RMLC1 | FDA UDI | Class II | Active |
| Luna-Orea | OREA9818RMLC4 | FDA UDI | Class II | Active |
| Luna-Orea | OREA9820RMLB1 | FDA UDI | Class II | Active |
| Luna | LOD10010TD3 | FDA UDI | Class II | Active |
| Iluzion | LZN9825RD4 | FDA UDI | Class II | Active |
| Luna | PMMA9814A3 | FDA UDI | Class II | Active |
| Luna | PMMA4019C2 | FDA UDI | Class II | Active |
| Orea Plus | OREAPL9822A2 | FDA UDI | Class II | Active |
| Orea Plus | OREAPL9810C4 | FDA UDI | Class II | Active |
| Iluzion | LZN6525C2 | FDA UDI | Class II | Active |
| Luna-Orea | OCL100C4 | FDA UDI | Class II | Active |
| Luna-Orea | OREA9818MLD2 | FDA UDI | Class II | Active |
| Luna | LOD10010TC2 | FDA UDI | Class II | Active |
| Luna | LCL20B4 | FDA UDI | Class II | Active |
| Luna | LS8540TC2 | FDA UDI | Class II | Active |
| Luna-Orea | OREA9825MLB2 | FDA UDI | Class II | Active |
| Luna | LZ9514TB1 | FDA UDI | Class II | Active |
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