Cleared Traditional

K081402 - SIMPLANT ORTHO

Also marketed or referenced as:
VISTADENT 3D

K081402 is an FDA 510(k) clearance for SIMPLANT ORTHO, manufactured by Materialise Dental NV. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K081402 · Materialise Dental NV · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2008
Decision
60d
Days
Class 2
Risk

K081402 is an FDA 510(k) clearance for the SIMPLANT ORTHO. 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 Materialise Dental NV (Leuven, BE). The FDA issued a Cleared decision on July 18, 2008 after a review of 60 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.

FDA 510(k) Submission Details - K081402

510(k) Number K081402 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 19, 2008
Decision Date July 18, 2008
Days to Decision 60 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 107d · This submission: 60d
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 2258
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K081402.
FIATLUX VISUALIZE
K082041 · Fiatlux Imaging, Inc. · Aug 2008
MAMMO WORKSTATION
K081630 · Image Diagnost International GmbH · Jul 2008
IMPAX MA3000 DIAGNOSTIC PACS WORKSTATION
K081976 · Agfa Healthcare Corporation · Jul 2008
STEALTHVIZ ADVANCED PLANNING APPLICATION WITH STEALTHDTI PACKAGE
K081512 · Medtronic Navigation, Inc. · Jul 2008
QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI
K080905 · Quantum Medical Imaging, LLC · Jul 2008
ULTRASOUND DATA ANALYSIS SYSTEM, MODEL DAS-RS1
K081843 · Aloka Co., Ltd. · Jul 2008
K081402 · SIMPLANT ORTHO
Download PDF FDA Summary Materialise Dental NV