IGI-System
by Denx Advanced Dental Systems 2 variants
510(k) K052840
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK052840 | Date16 Dec 2005 | 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- Withdrawn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
- HAW
- Device Class
- Class II
- Regulation
- 21 CFR Part 882.4560
- Advisory Committee
- Neurology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The IGI-System is a stereotaxic instrument (per 21 CFR 882.4560), designed to facilitate precise dental implant placement. It integrates computer-assisted planning with real-time alignment, enabling surgeons to achieve accurate positioning of implants based on pre-operative imaging.
This device is supplied as a reusable system for use in dental surgery settings. It requires sterile components during clinical application and is classified as a Class II medical device under FDA regulations. The system operates independently of MRI environments and is authorised via FDA 510(k) clearance (K052840).
Other devices from Denx Advanced Dental Systems
Questions
AI-generated answers, 19 Sep 2026
What is the IGI-System primarily used for in dental surgery and how does it differ from traditional implant placement methods?
The IGI-System is designed to assist surgeons in placing dental implants with high precision using stereotaxic techniques. Unlike traditional methods that rely solely on manual placement, it integrates computer-assisted planning with real-time alignment, allowing for accurate positioning based on pre-operative imaging. This reduces guesswork and improves outcomes by ensuring implants are placed according to pre-determined surgical guides.
Is the IGI-System compatible with MRI environments, and if not, why does this matter for dental clinics?
No, the IGI-System is explicitly designed to operate independently of MRI environments. This matters because dental clinics may need to accommodate patients with MRI contraindications or those who require follow-up imaging. The system’s non-MRI compatibility ensures it won’t interfere with such procedures or pose risks to patients who cannot safely enter an MRI scanner.
How is the IGI-System supplied, and what does ‘sterile components’ mean in this context for clinical use?
The IGI-System is supplied as a reusable device, but during clinical use, specific components must be sterilized to maintain infection control standards. This means while the core system itself can be reused across multiple procedures, disposable or single-use attachments (like surgical guides or probes) are provided sterile to ensure patient safety and compliance with aseptic techniques.
What does the FDA’s classification of the IGI-System as Class II imply about its regulatory oversight and safety standards?
The IGI-System’s classification as a Class II device under FDA regulations means it is subject to stricter controls than Class I but not as rigorous as Class III. This includes mandatory performance standards, post-market surveillance, and compliance with specific labeling requirements to ensure its safety and effectiveness. The FDA’s 510(k) clearance (K052840) confirms it meets these standards and is deemed substantially equivalent to a legally marketed predicate device.