Home / 510(k) Clearances / K182712

510(k) K182712

DEXIS CariVu 3-in-1 by KaVo by Kaltenbach & Voigt GmbH — Product Code NTK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 23, 2019
Date Received
September 27, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Caries Detector, Laser Light, Transmission
Device Class
Class II
Regulation Number
872.1745
Review Panel
DE
Submission Type

Other clearances by Kaltenbach & Voigt GmbH

  • K181110 — PROPHYflex 4 (April 10, 2019)
  • K163239 — SMARTmatic (March 17, 2017)
  • K161488 — ESTETICA Dental Treatment Unit and Accessories (December 8, 2016)
  • K143465 — MASTERmatic LUX (April 9, 2015)
  • K140308 — MASTERSURG / EXPERTSURG (August 15, 2014)
  • K130560 — MASTERTORQUE LUX 8900 L (September 27, 2013)
  • K123402 — DIAGNOCAM (September 24, 2013)
  • K103027 — ELECTROTORQUE TLC (August 19, 2011)

Other clearances for product code NTK

  • K250771 — Primescan 2 (August 29, 2025)
  • K240573 — iTero Lumina™ Pro (August 16, 2024)
  • K213482 — TIA Tip, Cariosity, Transillumination Accessory Tip (April 29, 2022)
  • K193659 — iTero Element 5D (March 20, 2020)
  • K172007 — CamX Triton HD Proxi Head (November 22, 2017)
  • K123402 — DIAGNOCAM (September 24, 2013)
  • K071429 — TI2200 TRANSILLUMINATION CABLE (September 10, 2007)
  • K062961 — MICROLUX TRANSILLUMINATOR (February 8, 2007)
  • K060080 — DIAGNODENT 2190 WITH PERIODONTAL PROBE (February 8, 2006)
  • K043068 — DIFOTI USB 2.0 SYSTEM (December 29, 2004)