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Sign in to claim this brandFUSION DENTAL IMPLANTS LLC
US
Last updated May 23, 2026
What FUSION DENTAL IMPLANTS LLC makes
Fusion Dental Implants LLC manufactures two-piece basket endosteal dental implants designed for osseointegration in the jawbone. Their portfolio includes the NBB External Hex implant, which features an external hex connection for abutment attachment. These devices are intended for use in dental restoration procedures requiring stable, long-term fixation.
The company’s products are classified as Class II medical devices under US regulations and are listed in the FDA’s Unique Device Identifier (UDI) database. These implants are intended for commercial distribution within the United States, adhering to applicable FDA requirements for dental implants.
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 Fusion Dental Implants LLC manufacture?
Fusion Dental Implants LLC specializes in two-piece basket endosteal dental implants, specifically designed for osseointegration in the jawbone. Their primary product, the NBB External Hex, features an external hex connection for securing abutments, enabling stable dental restoration. These implants are engineered for long-term fixation in procedures requiring durable jawbone integration.
Where is Fusion Dental Implants LLC based, and where are its devices intended for use?
Fusion Dental Implants LLC is based in the United States. Their dental implants, including the NBB External Hex, are intended for commercial distribution within the US market, adhering to applicable FDA regulations for dental implant devices.
How are Fusion Dental Implants LLC’s devices classified under US regulations?
Fusion Dental Implants LLC’s devices, such as the NBB External Hex, are classified as Class II medical devices under US regulations. This classification applies due to their role in dental restoration, where moderate risk is associated with improper use or failure, requiring special controls beyond general controls to ensure safety and effectiveness.
Are Fusion Dental Implants LLC’s devices listed in any regulatory registries?
Yes, Fusion Dental Implants LLC’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 patients to verify device details, including manufacturer information, model specifications, and lot numbers.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- 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
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- DUNS Number
- 081135800
Catalogue (26)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| NBB External Hex | 4.1 Lock-Attach Abutment | FDA UDI | Class II | Active |
| NBB External Hex | 4.1 Lock-Attach Abutment | FDA UDI | Class II | Active |
| NBB External Hex | 3.5 Abutment Screw | FDA UDI | Class II | Active |
| NBB External Hex | 4.1 Lock-Attach Abutment | FDA UDI | Class II | Active |
| NBB External Hex | 4.1 Lock-Attach Abutment | FDA UDI | Class II | Active |
| NBB External Hex | 3.5 Lock-Attach Abutment | FDA UDI | Class II | Active |
| NBB External Hex | 3.5 Temp Abutment | FDA UDI | Class II | Active |
| NBB External Hex | 4.1 Lock-Attach Abutment | FDA UDI | Class II | Active |
| NBB External Hex | 4.1 Non Eng Temp Abutment | FDA UDI | Class II | Active |
| NBB External Hex | 3.5 Multi-unit Abutment | FDA UDI | Class II | Active |
| NBB External Hex | 3.5 Lock-Attach Abutment | FDA UDI | Class II | Active |
| NBB External Hex | 4.1 Lock-Attach Abutment | FDA UDI | Class II | Active |
| NBB External Hex | 3.5 Healing Abutment | FDA UDI | Class II | Active |
| NBB External Hex | 3.5 Multi-unit Abutment | FDA UDI | Class II | Active |
| NBB External Hex | 3.5 Lock-Attach Abutment | FDA UDI | Class II | Active |
| NBB External Hex | 4.1 Eng Abutment 10mm | FDA UDI | Class II | Active |
| NBB External Hex | 4.1 Eng Abutment | FDA UDI | Class II | Active |
| NBB External Hex | 3.5 Lock-Attach Abutment | FDA UDI | Class II | Active |
| NBB External Hex | 3.5 Multi-unit Abutment | FDA UDI | Class II | Active |
| NBB External Hex | 4.1 Non Eng Abutment | FDA UDI | Class II | Active |
| NBB External Hex | 3.5 Healing Abutment | FDA UDI | Class II | Active |
| NBB External Hex | 3.5 Lock-Attach Abutment | FDA UDI | Class II | Active |
| NBB External Hex | 4.1 Temp Abutment | FDA UDI | Class II | Active |
| NBB External Hex | 3.5 Non Eng Abutment | FDA UDI | Class II | Active |
| NBB External Hex | 3.5 Eng Abutment | FDA UDI | Class II | Active |
| NBB External Hex | 4.1 Eng Abutment 7mm | FDA UDI | Class II | Active |
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