Cleared Traditional

K060267 - VIRTUAL IMPLANT PLACEMENT (VIP) DENTAL IMPLANT SURGERY PLANNING SOFTWARE

K060267 is an FDA 510(k) clearance for VIRTUAL IMPLANT PLACEMENT (VIP) DENTAL ..., manufactured by Implant Logic Systems, Ltd.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 44-day FDA review.

K060267 · Implant Logic Systems, Ltd. · Radiology device
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Mar 2006
Decision
44d
Days
Class 2
Risk

K060267 is an FDA 510(k) clearance for the VIRTUAL IMPLANT PLACEMENT (VIP) DENTAL IMPLANT SURGERY PLANNING SOFTWARE. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Implant Logic Systems, Ltd. (Deer Field, US). The FDA issued a Cleared decision on March 17, 2006 after a review of 44 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Implant Logic Systems, Ltd. devices

FDA 510(k) Submission Details - K060267

510(k) Number K060267 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2006
Decision Date March 17, 2006
Days to Decision 44 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 107d · This submission: 44d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1442
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