Virtual Implant Placement (VIP) Dental Implant Surgery Planning Software
by Implant Logic Systems, Ltd.
510(k) K060267
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK060267 | Date17 Mar 2006 | 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- Withdrawn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, 28 Sep 2026
Virtual Implant Placement (VIP) Dental Implant Surgery Planning Software is a PC-based software tool for dental implant surgery pre-planning. It processes DICOM CT scan images from external scanners to allow clinicians to remove non-relevant data and reformat axial CT data into panoramic and cross-sectional views. The software provides measurement tools for distance, angle, rectangular, and elliptical measurements and enables placement of virtual generic or manufacturer-specific implant models to assess size and position relative to patient anatomy.
It is used by dentists in clinical settings to evaluate bone density and anatomy for surgical planning. The software is supplied as a non-sterile or non-sterile status is not specified in the data, and no information is provided regarding single-use or reusable designation, MRI safety, sizes, storage conditions, or authorisations beyond the FDA 510(k) clearance under product code LLZ and K-number K060267.
Questions
AI-generated answers, 28 Sep 2026
What is the VIP Dental Implant Surgery Planning Software used for?
The VIP software is a PC-based tool used by dentists in clinical settings to pre-plan dental implant surgery by processing DICOM CT scan images, removing irrelevant data, reformatting views, and placing virtual implant models to assess size and position relative to patient anatomy, including bone density evaluation.
How is the VIP software supplied and what are its sterility and reuse characteristics?
The VIP software is supplied as a non-sterile PC-based software tool; the data does not specify whether it is single-use or reusable, as it is a digital planning application not involving physical contact with patients during use.
What regulatory clearance does the VIP software have and under what product code?
The VIP software received FDA 510(k) clearance under product code LLZ with K-number K060267, determined to be substantially equivalent to a predicate device following a traditional review process by the Radiology advisory committee.