Cleared Traditional

TIA Tip, Cariosity, Transillumination Accessory Tip

K213482 · D4D Technologies, LLC · Dental
Apr 2022
Decision
182d
Days
Class 2
Risk

About This 510(k) Submission

K213482 is an FDA 510(k) clearance for the TIA Tip, Cariosity, Transillumination Accessory Tip, a Caries Detector, Laser Light, Transmission (Class II — Special Controls, product code NTK), submitted by D4D Technologies, LLC (Richardson, US). The FDA issued a Cleared decision on April 29, 2022, 182 days after receiving the submission on October 29, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.1745.

Submission Details

510(k) Number K213482 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 2021
Decision Date April 29, 2022
Days to Decision 182 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code NTK — Caries Detector, Laser Light, Transmission
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1745