Cleared Traditional

K113739 - SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM

K113739 is an FDA 510(k) clearance for SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM, 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 162-day FDA review.

K113739 · Materialise Dental NV · Radiology device
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May 2012
Decision
162d
Days
Class 2
Risk

K113739 is an FDA 510(k) clearance for the SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM. 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 May 30, 2012 after a review of 162 days - an extended review 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 Materialise Dental NV devices

FDA 510(k) Submission Details - K113739

510(k) Number K113739 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 2011
Decision Date May 30, 2012
Days to Decision 162 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
55d slower than avg
Panel avg: 107d · This submission: 162d
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 1272
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K113739.
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
K120648 · Fujifilm Medical System U.S.A., Inc. · Jun 2012
SCENIUM 2.0
K121074 · Siemens Medical Solutions USA, Inc. · Jun 2012
SYNAPSE 3D NODULE ANALYSIS
K120679 · Fujifilm Medical Systems U.S.A, Inc. · Jun 2012
QLAB WITH FHN AND VPQ PLUG-IN
K121223 · Philips Ultrasound, Inc. · May 2012
SYNAPSE 3D BRAIN PERFUSION
K120637 · Fujifilm Medical System U.S.A., Inc. · May 2012
SURGICASE CONNECT
K113599 · Materialise NV · Apr 2012