Cleared Traditional

K081961 - 3M UNITEK LAVA CHAIRSIDE ORAL SCANNER

K081961 is an FDA 510(k) clearance for 3M UNITEK LAVA CHAIRSIDE ORAL SCANNER, manufactured by Brontes Technologies. The device is a Class 2 Dental device with product code NOF cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K081961 · Brontes Technologies · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
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.

FDA 510(k) Submission Details - K081961

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 128d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NOF Device Classification - Class 2, Special Controls

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.

Regulatory Peers - NOF System, Optical Impression, Computer Assisted Design And Manufacturing (cad/cam) Of Dental Restorations

Devices cleared under the same product code (NOF) and FDA review panel - the closest regulatory comparables to K081961.
LYTHOS DIGITAL IMPRESSION SYSTEM
K141611 · Ormco Corp. · Dec 2014
DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE
K122065 · Ormco Corp. · Feb 2013
3M TRUE DEFINITION SCANNER
K122467 · 3M Company · Nov 2012
3M ESPE LAVA CHAIRSIDE ORAL SCANNER
K073199 · Brontes Technologies · Dec 2007
K081961 · 3M UNITEK LAVA CHAIRSIDE ORAL SCANNER
Download PDF FDA Summary Brontes Technologies