TALLADIUM ESPAÑA SL

Talladium España SL specializes in reusable dental tools and implantology components. Their portfolio includes dental implant holding endpieces (used to secure implants during procedures), laboratory abutment analogs (for creating crowns or bridges), permanent preformed suprastructures (final dental restorations), and dental implant analogs (for practice or training). They also produce dental prosthesis/implant abutment screws, steel dental burs, surgical screwdrivers, and torque wrench adaptors—all designed for dental and surgical applications.

Talladium España SL is based in the US, which means their devices are subject to FDA regulations. Since their products are listed in the FDA’s Unique Device Identifier (UDI) database, they comply with U.S. traceability and labeling requirements. The FDA classifies their devices as either Class I (generally low-risk) or Class II (moderate-risk), requiring specific regulatory pathways for authorization.

Talladium España SL’s devices are included in the FDA’s Unique Device Identifier (UDI) database, which is a central registry for tracking medical devices authorized in the U.S. This database ensures transparency in device identification, manufacturing sourcing, and compliance with FDA requirements. The listing helps healthcare providers and regulators verify device details and traceability.

The FDA categorizes Talladium España SL’s devices as either Class I or Class II based on risk. Class I devices, like some reusable dental tools, typically pose minimal risk and may require general controls (e.g., proper labeling, manufacturing practices). Class II devices, such as certain implant components or surgical instruments, involve moderate risks and may require additional performance standards or post-market surveillance to ensure safety and effectiveness.

Listing in the FDA’s UDI system ensures that each device has a unique identifier, improving traceability for recalls, adverse events, or post-market monitoring. This helps healthcare providers verify device authenticity, track supply chains, and comply with FDA reporting requirements. For regulated entities, it also demonstrates adherence to U.S. medical device regulations, supporting transparency in the clinical and commercial use of their products.