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Diagnostic devices · 21 CFR 872 Subpart B

Light-Induced Fluorescence Caries Detector

FDA device type “Light-Induced Fluorescence Caries Detector ”.

FDA codeNBLClass221 CFR872.1745Pathway510(k)CategoryCaries detection devices
Companies listing it
1513 makers
Brands and models
34
510(k) clearances
246 in five years
FDA name
Light-Induced Fluorescence Caries Detector
2000: 12004: 12005: 32007: 12009: 22010: 22011: 12012: 22013: 12016: 12017: 12018: 12020: 12022: 12023: 12024: 22025: 12026: 119801990200020102020

510(k) clearances per year, 1976–2026

Companies that list NBL

15 companies currently list this device type with FDA.

CompanyCountryRoleBrands and models listedClearancesLatest
Dentsply Sirona, Inc.United StatesMaker—1482026
3Shape TriosDenmarkMakerL1P-1F · Trios 5 (L1P-1F) · Trios Ready Tip32026
Satelec - Acteon GroupUnited StatesMakerC50 · Caries Detection Device · Laser Flourescence Caries Detection · Mini Dock U USB2 · +2182024
Durr Dental SEGermanyMakerCamX Spectra · CamX Triton HD Spectra62023
Good Doctors Co., Ltd.South KoreaMakerIC-WHCD100 (Inspire) · Polaroid P3152023
KaVo Dental GmbHGermanyMaker0.574500 - DIAGNOdent 2095 · 104.1640 - DIAGNOdent 2095 perio tip · 111.1213 - DIAGNOcam Vision Full HD · 111.4444 - DEXIS CariVu 3-in-1 by KaVo · +322021
AIOBIO Co., Ltd.South KoreaMakerLINKDENS QC · Qraycam PRO22024
Zumax Medical Co., Ltd.ChinaMakerOMS2360 Surgical Microscope · OMS2380 Surgical Microscope12026
Smartooth Co., Ltd.South KoreaMakerSmarTooth12024
3Shape A/SDenmarkMakerL1P-1F · Trios 5 (L1P-1F)72020
Marturion Electronics LtdUnited KingdomMakerOrtek ECD——
Carl Zeiss Meditec AG (Jena)GermanyMakerFluorescence mode——
JENOPTIK Optical Systems GmbHGermanyMaker———
A-dec, Inc.United StatesManufacturerDIAGNOcam Vision Full HD Intaoral Camera682022
DCI International LLCUnited StatesManufacturerKit, Mini Dock U-USB2, w/o Camera, Acteon, Light Gray · Kit, Mini Dock U-USB2, w/o Camera, Acteon, Series 5, Light Gray · Kit, Mini Dock U-USB2, w/o Camera, Acteon, White · Mini Dock U-USB2, Light Gray, Intra-Oral Camera, Acteon12025

510(k) clearances

Decided510(k)DeviceApplicant
28 Apr 2026K252464Surgical Microscope (OMS2360, OMS2380)Zumax Medical Co., Ltd.
4 Apr 2025K242103TRIOS Ready Tip3Shape Trios
4 Sep 2024K221275Qraycam PROAIOBIO Co., Ltd.
1 May 2024K231722SmarToothSmartooth Co., Ltd.
14 Dec 2023K223470C50Satelec - Acteon Group
16 Sep 2022K221249L1P-1F (TRIOS 5)3Shape Trios
2 Jul 2020K183471IC-WHCD100 (Inspire)Good Doctors Co., Ltd.
3 May 2018K171007Fluorescence ModeCarl Zeiss Suzhou Co., Ltd.
11 Sep 2017K170822Electronic Caries DetectorOrtek Therapeutics, Inc.
27 Jan 2016K150672VistaCam iX ProofDurr Dental AG
12 Mar 2013K121685SOPROCARESatelec - Acteon Group
26 Oct 2012K112139THE CANARY SYSTEMQuantum Dental Technologies, Inc.
2 Mar 2012K111423CS 1600 INTRAORAL CAMERACarestream Health, Inc.
17 May 2011K111321REMOTE VIEW SOFTWARECariescan , Ltd.
23 Apr 2010K093705FUORECAMTherapeutic Technologies, Inc.
13 Jan 2010K092583SOPROLIFESatelec - Acteon Group
15 Dec 2009K090598CARIESCAN PROCariescan , Ltd.
18 Aug 2009K090169SPECTRA FLUORESCENCE CARIES DETECTION DEVICEDuerr Dental SE
30 Mar 2007K063321D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138Neks Technologies, Inc.
21 Oct 2005K051909DIAGNODENTKavo America
2 Aug 2005K042394DIAGNODENT PERIO TIP (ACCESSORY)Kavo America
28 Apr 2005K043156D-CARIE, MODEL N121-M1Neks Technologies, Inc.
24 Jun 2004K040063INSPEKTOR PROInspektor Dental Care BV
22 Feb 2000DEN990002KAVO DIAGNODENTKavo America

Official records: FDA product classification for NBL · 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