ConeLog Titanium Base CAD/CAM
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
by ALTATEC GmbH
Identifiers
- 510(k) Number
- K143337 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 ConeLog Titanium Base CAD/CAM is a dental implant abutment system designed for computer-aided design and manufacturing (CAD/CAM) applications. It features a titanium base intended for use in dental prosthetics, providing a stable foundation for crowns, bridges, or other dental restorations with precise fit and alignment.
This device is supplied as a reusable component within a dental laboratory or clinical setting, requiring sterilization before use. The titanium base is compatible with standard dental CAD/CAM workflows and adheres to regulatory standards, including FDA 510(k) clearance under the Dental advisory committee classification. Its design ensures compatibility with MRI environments and is intended for single-patient use per manufacturer specifications.
Frequently asked questions
What types of dental restorations can the ConeLog Titanium Base CAD/CAM be used for, and why is titanium preferred in this context?
The ConeLog Titanium Base CAD/CAM is designed to serve as a stable foundation for crowns, bridges, and other dental restorations, ensuring precise fit and alignment. Titanium is preferred in dental implants and abutments due to its biocompatibility, strength, and ability to integrate well with bone tissue, reducing the risk of rejection or inflammation.
Is the ConeLog Titanium Base CAD/CAM intended for single-patient use, and how does this affect its reuse in a clinical setting?
Yes, the ConeLog Titanium Base CAD/CAM is specified for single-patient use by the manufacturer. While it is reusable within a dental laboratory or clinical setting, it must be sterilized before each use to ensure safety and compliance with infection control protocols. This means it cannot be reused across multiple patients without proper sterilization.
How does the ConeLog Titanium Base CAD/CAM integrate with existing dental workflows, particularly those involving CAD/CAM technology?
The ConeLog Titanium Base CAD/CAM is explicitly designed for compatibility with standard dental CAD/CAM workflows, allowing for precise digital planning and manufacturing of dental restorations. Its integration ensures that the abutment can be accurately fabricated to match the patient’s specific dental anatomy, improving the fit and longevity of the final restoration.
Can the ConeLog Titanium Base CAD/CAM be used in patients who require MRI scans, and why is this an important consideration?
Yes, the ConeLog Titanium Base CAD/CAM is designed to be MRI-compatible, meaning it can be safely used in patients who require magnetic resonance imaging. This is an important consideration because traditional metal dental implants or abutments may interfere with MRI scans, potentially causing artifacts or safety risks. The titanium material and design mitigate these concerns.
What regulatory pathways does the ConeLog Titanium Base CAD/CAM follow, and what does this mean for clinicians or laboratories using it?
The ConeLog Titanium Base CAD/CAM has received FDA 510(k) clearance under the Dental advisory committee classification, indicating it is deemed substantially equivalent to a legally marketed predicate device. This means it meets the necessary safety and performance standards for use in dental applications in the U.S. Clinicians and laboratories can rely on this clearance as evidence of the device’s regulatory compliance, though they should always follow local guidelines and manufacturer instructions for proper use.
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K143337 | Class II | Active |
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Manufacturer
- Manufacturer
- ALTATEC GmbH
Sources (2)
- FDA 510(k) K143337 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026