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510(k) K123402

DIAGNOCAM by Kaltenbach & Voigt GmbH — Product Code NTK

K123402 is an FDA 510(k) premarket notification submitted by Kaltenbach & Voigt GmbH for the device "DIAGNOCAM". The FDA issued a decision of Substantially Equivalent on September 24, 2013. The device falls under product code NTK (Light Transmission Caries Detector), a Class II device regulated under 21 CFR 872.1745. Kaltenbach & Voigt GmbH has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 24, 2013
Date Received
November 5, 2012
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

Other clearances by Kaltenbach & Voigt GmbH

  • K182712 — DEXIS CariVu 3-in-1 by KaVo (November 23, 2019)
  • 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)
  • K103027 — ELECTROTORQUE TLC (August 19, 2011)

Other clearances for product code NTK

  • K261847 — iTero Lumina™ Pro (July 2, 2026)
  • 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)
  • K182712 — DEXIS CariVu 3-in-1 by KaVo (November 23, 2019)
  • K172007 — CamX Triton HD Proxi Head (November 22, 2017)
  • K071429 — TI2200 TRANSILLUMINATION CABLE (September 10, 2007)
  • K062961 — MICROLUX TRANSILLUMINATOR (February 8, 2007)
  • K060080 — DIAGNODENT 2190 WITH PERIODONTAL PROBE (February 8, 2006)

FDA data resources