coDiagnostiX Implant Planning Software
510(k) K130724
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK130724 | Date28 Jun 2013 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- LLZ
- Device Class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory Committee
- Radiology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The coDiagnostiX Implant Planning Software is a digital dental planning tool designed for pre-surgical assessment and treatment planning of dental implants. It falls under the category of radiology-based diagnostic software, enabling clinicians to visualize implant placement, assess bone structure, and optimize prosthetic design using digital imaging data. The software integrates with existing workflows to enhance precision and patient communication through 3D visualization tools.
This software is supplied as a subscription-based digital solution, intended for use in dental clinics, oral surgery centers, and dental laboratories. It operates on standard computing platforms and requires no physical sterilization or single-use considerations, as it is entirely software-driven. The system is FDA-cleared under 510(k) K130724, classified under product code LLZ for radiology-related devices. No specific MRI safety or sterility requirements apply, as it is non-invasive and non-physical. Availability may vary by region, subject to local regulatory and subscription agreements.
Other devices from Straumann USA
Questions
AI-generated answers, 1 Oct 2026
What is the coDiagnostiX Implant Planning Software used for?
The coDiagnostiX Implant Planning Software is a digital tool designed specifically for pre-surgical dental implant assessment and treatment planning. It uses radiology-based imaging data to help clinicians visualize potential implant placement, evaluate bone density and structure, and refine prosthetic designs. This integration into existing workflows improves precision, reduces surgical risks, and enhances patient communication through interactive 3D visualizations.
How is the coDiagnostiX software supplied and does it require sterilization?
The coDiagnostiX Implant Planning Software is supplied exclusively as a subscription-based digital solution. Since it is entirely software-driven and operates on standard computing platforms, no physical sterilization or single-use considerations apply. It does not require sterilization procedures, as it is non-invasive and does not interact with patients directly.
Is the software compatible with all dental imaging data, or does it require specific formats?
The coDiagnostiX software is designed to integrate with existing dental imaging workflows, though the exact supported formats are not detailed in the provided data. Clinicians should confirm compatibility with their specific imaging systems before adoption. The software’s primary function relies on digital imaging data to enable accurate implant planning and visualization.
Does the coDiagnostiX software have any special storage or maintenance requirements?
As a digital solution, the coDiagnostiX software does not require specialized storage beyond standard computing infrastructure. It operates on typical dental clinic or laboratory computers, so no additional hardware or environmental controls (e.g., temperature, humidity) are mandated. Regular software updates may be required to maintain functionality, but these are managed through the subscription model.
What regulatory approval does the coDiagnostiX Implant Planning Software hold?
The coDiagnostiX Implant Planning Software holds FDA clearance under 510(k) number K130724, classified under product code LLZ for radiology-related devices. This clearance confirms its substantial equivalence to a predicate device, ensuring it meets regulatory standards for digital dental planning tools. Availability may still vary by region based on local regulatory and subscription agreements.