Cleared Traditional

3M UNITEK LAVA CHAIRSIDE ORAL SCANNER (K081961) - FDA 510(k) Clearance

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

K081961 · Brontes Technologies · Dental device
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Optimized for regulatory review, auditing and printing
Sep 2008
Decision
58d
Days
Class 2
Risk

K081961 is an FDA 510(k) clearance for the 3M UNITEK 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 September 5, 2008 after a review of 58 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.

View all Brontes Technologies devices

Submission Details

510(k) Number K081961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2008
Decision Date September 05, 2008
Days to Decision 58 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
69d faster than avg
Panel avg: 127d · This submission: 58d
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.