Cleared Traditional

3M ESPE LAVA CHAIRSIDE ORAL SCANNER (K073199) - FDA 510(k) Clearance

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

K073199 · Brontes Technologies · Dental device
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Optimized for regulatory review, auditing and printing
Dec 2007
Decision
38d
Days
Class 2
Risk

K073199 is an FDA 510(k) clearance for the 3M ESPE LAVA CHAIRSIDE ORAL SCANNER. Classified as System, Optical Impression, Computer Assisted Design And Manufacturing (cad/cam) Of Dental Restorations (product code NOF), Class II - Special Controls.

Submitted by Brontes Technologies (South West Ranches, US). The FDA issued a Cleared decision on December 21, 2007 after a review of 38 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

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Submission Details

510(k) Number K073199 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2007
Decision Date December 21, 2007
Days to Decision 38 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
89d faster than avg
Panel avg: 127d · This submission: 38d
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.