Cleared Traditional

SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM (K113739) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K113739 · Materialise Dental NV · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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.

Device Classification

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 730
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K113739.
DYNAPBV BODY SOFTWARE
K121292 · Siemens Medical Solutions USA, Inc. · Jul 2012
SYNGO.MR NEUROLOGY
K121459 · Siemens Medical Solutions USA, Inc. · Jun 2012
SCENIUM 2.0
K121074 · Siemens Medical Solutions USA, Inc. · Jun 2012
SYNGO.MR SPECTRO ENGINE, SYNGO.MR SPECTRO SVS, SYNGO.MR SPECTRO CSI, SYNGO.MR SPECTRO EXTENSION
K120315 · Siemens Medical Solutions USA, Inc. · Apr 2012
VIEW 1 IMAGING
K112480 · KARL STORZ Endoscopy-America, Inc. · Dec 2011
SYNGO VIA MI WORKFLOWS
K113029 · Siemens Medical Solutions USA, Inc. · Nov 2011