SPI Titanium Base for CAD/CAM
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K102804 FDA 510(k)
- FDA Product Code
- NHA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3630 FDA 510(k)
- Regulation Number
- 872.3630 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The SPI Titanium Base for CAD/CAM is a dental implant abutment designed for use in computer-aided design and computer-aided manufacturing (CAD/CAM) restorative procedures. It serves as a foundation component for dental prosthetics, providing a stable interface between dental implants and crowns or bridges. Constructed from titanium, this base is intended to integrate with implant systems to support precise and durable restorative solutions. Its design aligns with modern dental restoration workflows, facilitating customised fit and function in prosthetic dentistry.
This titanium base is supplied as a reusable component for dental professionals in clinical settings. It is intended for use with compatible CAD/CAM systems and dental implant platforms, requiring proper sterilisation and handling per manufacturer guidelines. The device is classified under product code NHA and holds FDA 510(k) clearance, demonstrating substantial equivalence to predicate devices. Storage and preparation must adhere to dental best practices to ensure compatibility and longevity in restorative applications.
Frequently asked questions
What is the SPI Titanium Base for CAD/CAM used for in dental procedures?
The SPI Titanium Base for CAD/CAM serves as a critical foundation in dental implant restorations, acting as an abutment between the implant fixture and prosthetic crowns or bridges. Its titanium construction ensures biocompatibility and strength, while its design aligns with modern CAD/CAM workflows to enable customised, precise prosthetic fits. This makes it ideal for clinicians seeking durable, long-term solutions in implant-supported restorative dentistry.
Is the SPI Titanium Base for CAD/CAM reusable or single-use?
The SPI Titanium Base for CAD/CAM is explicitly designed as a reusable component for clinical use. Its durable titanium construction allows for repeated sterilisation and application across multiple patients, provided proper handling and sterilisation protocols—per manufacturer guidelines—are followed. This design supports cost-effective workflows in dental practices while maintaining hygiene standards.
How should the SPI Titanium Base for CAD/CAM be stored to ensure compatibility?
Storage of the SPI Titanium Base for CAD/CAM must adhere to dental best practices to preserve its integrity and compatibility with CAD/CAM systems. It should be kept in a clean, dry environment, protected from physical damage or contamination. Before use, the base must undergo thorough sterilisation as recommended by Thommen Medical AG to ensure sterility and readiness for prosthetic applications. Improper storage could compromise its precision or sterility.
What regulatory clearance does the SPI Titanium Base for CAD/CAM hold?
The SPI Titanium Base for CAD/CAM holds FDA 510(k) clearance, demonstrating substantial equivalence to predicate devices under product code NHA. This clearance was granted through a traditional review process by the FDA’s Dental Advisory Committee (DE) in 2011, confirming its compliance with safety and effectiveness standards for dental implant abutments. The clearance does not imply clinical indications but confirms regulatory alignment with existing dental implant systems.
Can this base be used with any CAD/CAM system or dental implant platform?
The SPI Titanium Base for CAD/CAM is designed to integrate with compatible CAD/CAM systems and dental implant platforms, but its use is contingent on proper system matching. Clinicians must verify compatibility with their specific implant system and CAD/CAM software to ensure seamless workflow integration. Thommen Medical AG’s guidelines should be consulted to confirm optimal pairing for precise restorative outcomes.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: PDF 510(k) Summary 20 2011 THOMMEN MEDICAL AG SPI® Titanium Base for ..., Download Center - Thommen Medical, Thommen Medical SPI - Zirkonzahn, Product catalog of the Thommen Implant System - Thommen Medical, SPI TITANIUM BASE FOR CAD/CAM (K102804) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K102804 | Class II | Active |
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Manufacturer
- Manufacturer
- Thommen Medical AG
Sources (1)
- FDA 510(k) K102804 24 fields · synced Oct 6, 2026