Cleared Traditional

K141611 - LYTHOS DIGITAL IMPRESSION SYSTEM (FDA 510(k) Clearance)

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

K141611 · Ormco Corp. · Dental device
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Dec 2014
Decision
172d
Days
Class 2
Risk

K141611 is an FDA 510(k) clearance for the LYTHOS DIGITAL IMPRESSION SYSTEM. Classified as System, Optical Impression, Computer Assisted Design And Manufacturing (cad/cam) Of Dental Restorations (product code NOF), Class II - Special Controls.

Submitted by Ormco Corp. (Orange, US). The FDA issued a Cleared decision on December 5, 2014 after a review of 172 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3661 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K141611 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 16, 2014
Decision Date December 05, 2014
Days to Decision 172 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
45d slower than avg
Panel avg: 127d · This submission: 172d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code NOF System, Optical Impression, Computer Assisted Design And Manufacturing (cad/cam) Of Dental Restorations
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.3661
Definition An Optical Impression System For Cad/cam Of Dental Restorations Is A Device Used To Record The Topographical Characteristics Of Teeth, Dental Impressions, Or Stone Models By Analog Or Digital Methods For Use In The Computer Aided Design And Manufacturing Of Dental Restorative Prosthetic Devices. Such Systems May Consist Of A Camera, Scanner, Or Equivalent Type Of Sensor And A Computer With Software.
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 Dental devices follow this clearance model.