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Diagnostic devices · 21 CFR 872 Subpart B

Light Transmission Caries Detector

FDA device type “Light Transmission Caries Detector”.

FDA codeNTKClass221 CFR872.1745Pathway510(k)CategoryCaries detection devices
Companies listing it
139 makers
Brands and models
30
510(k) clearances
124 in five years
FDA name
Light Transmission Caries Detector
2004: 12006: 12007: 22013: 12017: 12019: 12020: 12022: 12024: 12025: 12026: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list NTK

13 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Dentsply Sirona, Inc.United StatesMaker—1482026
Align Technology, Inc.United StatesMakeriTero Element 5D · iTero Element 5D Laptop Configuration · iTero Element 5D Laptop Configuration, Certified Pre-owned · iTero Element 5D Plus · +5162026
Durr Dental SEGermanyMakerCamX Triton HD Proxi62023
Planmeca OyFinlandMakerCariosity; TIA Tip; Transillumination Accessory Tip · Planmeca Emerald · Planmeca Emerald S252023
KaVo Dental GmbHGermanyMaker102.7000 - DIAGNOdent pen 2190 · 102.8568 - DIAGNOdent Paro Tip Saphir with scale · 104.8400 - DIAGNOdent Display 2191 · 104370 - DIAGNOdent Paro Tip Saphir without scale · +622021
Addent, Inc.United StatesMakerMicrolux 2 Transilluminator · Microlux DW Transilluminator · Microlux Mini Transilluminator · Microlux Transilluminator72019
Fabrinet Co., Ltd.ThailandMakeriTero Lumina (Scanning unit)——
I-Dent Innovations for Dentistry SASwitzerlandMaker———
JENOPTIK Optical Systems GmbHGermanyMaker———
A-dec, Inc.United StatesManufacturerDIAGNOcam Vision Full HD Intaoral Camera682022
Henry Schein, Inc.United StatesForeign exporterSmartlite Pro Sleeves Refill82004
Zapalign LLCUnited StatesRepacker / relabeler———
Oketz Logistics LLCUnited StatesRepacker / relabeler———

510(k) clearances

Decided510(k)DeviceApplicant
2 Jul 2026K261847iTero Lumina™ ProAlign Technology, Inc.
29 Aug 2025K250771Primescan 2Dentsply Sirona, Inc.
16 Aug 2024K240573iTero Lumina™ ProAlign Technology, Inc.
29 Apr 2022K213482TIA Tip, Cariosity, Transillumination Accessory TipD4D Technologies, LLC
20 Mar 2020K193659iTero Element 5DAlign Technology, Inc.
23 Nov 2019K182712DEXIS CariVu 3-in-1 by KaVoKaltenbach & Voigt GmbH
22 Nov 2017K172007CamX Triton HD Proxi HeadDuerr Dental AG
24 Sep 2013K123402DIAGNOCAMKaltenbach & Voigt GmbH
10 Sep 2007K071429TI2200 TRANSILLUMINATION CABLESybron Dental Specialties
8 Feb 2007K062961MICROLUX TRANSILLUMINATORAddent, Inc.
8 Feb 2006K060080DIAGNODENT 2190 WITH PERIODONTAL PROBEKaVo Dental GmbH
29 Dec 2004K043068DIFOTI USB 2.0 SYSTEMElectro-Optical Sciences, Inc.

Official records: FDA product classification for NTK · 21 CFR 872.1745.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026