Home / 510(k) Clearances / K213482

510(k) K213482

TIA Tip, Cariosity, Transillumination Accessory Tip by D4D Technologies, LLC — Product Code NTK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 2022
Date Received
October 29, 2021
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 D4D Technologies, LLC

  • K110511 — E4D COMPASS (March 11, 2011)

Other clearances for product code NTK

  • K250771 — Primescan 2 (August 29, 2025)
  • K240573 — iTero Lumina™ Pro (August 16, 2024)
  • 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)
  • 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)