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Sign in to claim this brandDENALI CORPORATION
US
Last updated May 24, 2026
What DENALI CORPORATION makes
Denali Corporation manufactures a range of dental products including composite resins, pit and fissure sealants, etching solutions, cavity varnishes, and non‑latex rubber dams, with specific devices such as AuraVeneer Cement, Super Liner, Zenith Implant Screw Mask, Triumph Resin Dam, AuraCore Buildup Material, AuraLay XF Pit and Fissure Sealant, Bonita Pit and Fissure Sealant, and Denali Etching Gel.
The portfolio includes Class I and Class II medical devices that are listed in the FDA 510(k) and FDA UDI registries, and the company 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 dental products does Denali Corporation manufacture?
Denali Corporation manufactures dental composite resins, pit and fissure sealants, etching solutions, cavity varnishes, and non-latex rubber dams. Specific products include AuraVeneer Cement, Super Liner, Zenith Implant Screw Mask, Triumph Resin Dam, AuraCore Buildup Material, AuraLay XF Pit and Fissure Sealant, Bonita Pit and Fissure Sealant, and Denali Etching Gel.
Where is Denali Corporation based?
Denali Corporation is based in the United States. The company operates from its headquarters located within the country, where it designs, manufactures, and distributes its dental products to various markets.
Which regulatory registries list Denali Corporation's devices?
Denali Corporation's devices are listed in the FDA 510(k) and FDA UDI registries. These listings indicate that the company's products have been submitted to the U.S. Food and Drug Administration for clearance and are assigned unique device identifiers for tracking purposes.
How are Denali Corporation's devices classified?
Denali Corporation's devices are classified as Class I and Class II medical devices. Class I devices are low-risk and subject to general controls, while Class II devices require special controls in addition to general controls to ensure their safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- denalicorporation.com
- —
- —
- [email protected]
- Phone
- +1-781-826-9190
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 191036107
Catalogue (43)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| AuraVeneer Cement | Off White | FDA UDI | Class II | Active |
| AuraVeneer Cement | 1 Off White - 3 Opaque White | FDA UDI | Class II | Active |
| Super Liner | Single Syringe - White | FDA UDI | Class II | Active |
| Zenith Implant Screw Mask | ZEN1 | FDA UDI | Class II | Active |
| Triumph Resin Dam | TRI | FDA UDI | Class I | Active |
| AuraCore Buildup Material | Single - Opaque White | FDA UDI | Class II | Active |
| AuraCore Buildup Material | Single - Natural Off White | FDA UDI | Class II | Active |
| AuraLay XF Pit and Fissure Sealant | 1.2 mL Natural Translucent | FDA UDI | Class II | Active |
| AuraLay Pit and Fissure Sealant | Opaque White | FDA UDI | Class II | Active |
| AuraVeneer Cement | Clear | FDA UDI | Class II | Active |
| Bonita Pit and Fissure Sealant | 1.2 mL Natural Translucent | FDA UDI | Class II | Active |
| Denali Etching Gel | Syringe 3 mL | FDA UDI | Class II | Active |
| AuraLay XF Pit and Fissure Sealant | 3 mL Natural Translucent | FDA UDI | Class II | Active |
| AuraCem DC90 Resin Cement | Off White | FDA UDI | Class II | Active |
| AuraOpaquer | 1.2 mL Pink | FDA UDI | Class II | Active |
| Denali Etching Gel | 12 mL Etching Gel | FDA UDI | Class II | Active |
| Jazzy DC Acrylic Resin | Single Double-Barrel Syringe | FDA UDI | Class II | Unknown |
| AuraVeneer Cement | 1 Opaque White | FDA UDI | Class II | Active |
| Harmony Implant Cement | Enamel White | FDA UDI | Class II | Active |
| AuraLay Pit & Fissure Sealant | 1.2 mL Natural Translucent | FDA UDI | Class II | Active |
| Aura Protective Sealer | 1.2 mL Clear | FDA UDI | Class II | Active |
| AuraLay XF Pit and Fissure Sealant | 1.2 mL Opaque White | FDA UDI | Class II | Active |
| AuraVeneer Cement | 3 Clear - 1 Off White | FDA UDI | Class II | Active |
| AuraVeneer Cement | 2 Clear - 2 Off-White | FDA UDI | Class II | Active |
| Bonita Pit and Fissure Sealant | 1.2 mL Opaque White | FDA UDI | Class II | Active |
| HIRO Light Cure Pattern, Modeling and Indexing Resin | One 3 mL Syringe | FDA UDI | Class II | Unknown |
| AuraVeneer Cement | 1 Clear - 3 Off White | FDA UDI | Class II | Active |
| AuraLay Pit and Fissure Sealant | 3 mL Opaque White | FDA UDI | Class II | Active |
| AuraLay XF Pit and Fissure Sealant | 3 mL Opaque White | FDA UDI | Class II | Active |
| Resolve Cleansing Gel | Single - Pink | FDA UDI | Class II | Active |
| AuraLay Pit and Fissure Sealant | 3 mL Natural Translucent | FDA UDI | Class II | Active |
| AuraOpaquer | 1.2 mL White | FDA UDI | Class II | Active |
| AuraCem DC 90 | Clear | FDA UDI | Class II | Active |
| ClearVue Pit & Fissure Sealant and Sealer | 1.2 mL Clear | FDA UDI | Class II | Active |
| Auraveneer Cement | K073101 | FDA 510(k) | Class II | Active |
| Auralay Pit & Fissure Sealant | K071158 | FDA 510(k) | Class II | Active |
| Resolve 2.0 | K152322 | FDA 510(k) | Class II | Active |
| Triumph Resin Dam | K151945 | FDA 510(k) | Class I | Active |
| Calcium Bridge | K153191 | FDA 510(k) | Class II | Active |
| Cercom Ii Cement | K132393 | FDA 510(k) | Class II | Active |
| Fusion Resin Cement And Core Kit | K070702 | FDA 510(k) | Class II | Active |
| Denali 501cement | K141503 | FDA 510(k) | Class II | Active |
| Auravue Pit & Fissure Sealant | K070693 | FDA 510(k) | Class II | Active |
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