Home / 510(k) Clearances / K081961

510(k) K081961

3M UNITEK LAVA CHAIRSIDE ORAL SCANNER by Brontes Technologies — Product Code NOF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 5, 2008
Date Received
July 9, 2008
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Device Class
Class II
Regulation Number
872.3661
Review Panel
DE
Submission Type

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.

Other clearances by Brontes Technologies

  • K073199 — 3M ESPE LAVA CHAIRSIDE ORAL SCANNER (December 21, 2007)

Other clearances for product code NOF

  • K141611 — LYTHOS DIGITAL IMPRESSION SYSTEM (December 5, 2014)
  • K122065 — DIGITAL IMPRESSION SYSTEM FOR ORTHODONTIC USE (February 8, 2013)
  • K122467 — 3M TRUE DEFINITION SCANNER (November 20, 2012)
  • K073199 — 3M ESPE LAVA CHAIRSIDE ORAL SCANNER (December 21, 2007)