Caries detection devices: manufacturers and brands
26 companies make or specify caries detection devices among the 35 that list one with FDA, under 74 brand and model names. FDA has issued 53 510(k) clearances in this category, 11 of them in the last five years.
510(k) clearances per year, 1976–2026
Caries detection device manufacturers
Makers first, then the most recently active. “Maker” means the company manufactures the device or owns its specifications; a “lister” repacks, relabels, imports or distributes it.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Align Technology, Inc. | United States | Maker | iTero Element 5D · iTero Element 5D Laptop Configuration · iTero Element 5D Laptop Configuration, Certified Pre-owned · iTero Element 5D Plus · +5 | 16 | 2026 |
| Zest Anchors, LLC | United States | Maker | — | 26 | 2026 |
| Ultradent Products, Inc. | United States | Maker | Sable Seek · Seek | 95 | 2026 |
| Kuraray Noritake Dental, Inc. | Japan | Maker | CARIES DETECTOR | 32 | 2025 |
| 3Shape Trios | Denmark | Maker | L1P-1F · Trios 5 (L1P-1F) · Trios Ready Tip | 3 | 2026 |
| Centrix, Inc. | United States | Maker | Expose' | 44 | 2025 |
| Satelec - Acteon Group | United States | Maker | C50 · Caries Detection Device · Laser Flourescence Caries Detection · Mini Dock U USB2 · +2 | 18 | 2024 |
| Durr Dental SE | Germany | Maker | CamX Spectra · CamX Triton HD Spectra · CamX Triton HD Proxi | 6 | 2023 |
| Planmeca Oy | Finland | Maker | Cariosity; TIA Tip; Transillumination Accessory Tip · Planmeca Emerald · Planmeca Emerald S | 25 | 2023 |
| Good Doctors Co., Ltd. | South Korea | Maker | IC-WHCD100 (Inspire) · Polaroid P31 | 5 | 2023 |
| KaVo Dental GmbH | Germany | Maker | 0.574500 - DIAGNOdent 2095 · 104.1640 - DIAGNOdent 2095 perio tip · 111.1213 - DIAGNOcam Vision Full HD · 111.4444 - DEXIS CariVu 3-in-1 by KaVo · +8 | 2 | 2021 |
| AIOBIO Co., Ltd. | South Korea | Maker | LINKDENS QC · Qraycam PRO | 2 | 2024 |
| GreenMark Biomedical Inc. | United States | Maker | LumiCare | 2 | 2025 |
| Zumax Medical Co., Ltd. | China | Maker | OMS2360 Surgical Microscope · OMS2380 Surgical Microscope | 1 | 2026 |
| Incisive Technologies Pty Ltd | Australia | Maker | BlueCheck | 1 | 2023 |
| Smartooth Co., Ltd. | South Korea | Maker | SmarTooth | 1 | 2024 |
| Pulpdent Corporation | United States | Maker | Snoop Caries Detecting Dye | 107 | 2021 |
| 3Shape A/S | Denmark | Maker | L1P-1F · Trios 5 (L1P-1F) | 7 | 2020 |
| Addent, Inc. | United States | Maker | Microlux 2 Transilluminator · Microlux DW Transilluminator · Microlux Mini Transilluminator · Microlux Transilluminator | 7 | 2019 |
| Fabrinet Co., Ltd. | Thailand | Maker | iTero Lumina (Scanning unit) | — | — |
| Marturion Electronics Ltd | United Kingdom | Maker | Ortek ECD | — | — |
| Carl Zeiss Meditec AG (Jena) | Germany | Maker | Fluorescence mode | — | — |
| I-Dent Innovations for Dentistry SA | Switzerland | Maker | — | — | — |
| Silgan Unicep | United States | Maker | — | — | — |
| JENOPTIK Optical Systems GmbH | Germany | Maker | — | — | — |
| Inter-Med, Inc. | United States | Contract manufacturer | Caries Red and Green | 7 | 2026 |
| A-dec, Inc. | United States | Manufacturer | DIAGNOcam Vision Full HD Intaoral Camera | 68 | 2022 |
| DCI International LLC | United States | Manufacturer | Kit, 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, Acteon | 1 | 2025 |
| Henry Schein, Inc. | United States | Foreign exporter | Smartlite Pro Sleeves Refill | 8 | 2004 |
| Patterson Companies, Inc. | United States | Foreign exporter | Caries Indicator | — | — |
| Zapalign LLC | United States | Repacker / relabeler | — | — | — |
| CBE Pure Solutions Pty Ltd | Australia | Repacker / relabeler | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Where caries detection devices are made
Number of makers in this category with a manufacturing establishment in the country.
FDA device types in this category
| Device type | Class | Regulation | Makers | Clearances |
|---|---|---|---|---|
| Light-Induced Fluorescence Caries DetectorNBL | 2 | 872.1745 | 13 | 24 |
| Caries Detection DeviceLFC | 2 | 872.1740 | 9 | 17 |
| Light Transmission Caries DetectorNTK | 2 | 872.1745 | 9 | 12 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 2 Jul 2026 | K261847 | iTero Lumina Pro | Align Technology, Inc. | NTK Light Transmission Caries Detector |
| 28 Apr 2026 | K252464 | Surgical Microscope (OMS2360, OMS2380) | Zumax Medical Co., Ltd. | NBL Light-Induced Fluorescence Caries Detector |
| 29 Aug 2025 | K250771 | Primescan 2 | Dentsply Sirona, Inc. | NTK Light Transmission Caries Detector |
| 4 Apr 2025 | K242103 | TRIOS Ready Tip | 3Shape Trios | NBL Light-Induced Fluorescence Caries Detector |
| 4 Sep 2024 | K221275 | Qraycam PRO | AIOBIO Co., Ltd. | NBL Light-Induced Fluorescence Caries Detector |
| 16 Aug 2024 | K240573 | iTero Lumina Pro | Align Technology, Inc. | NTK Light Transmission Caries Detector |
| 1 May 2024 | K231722 | SmarTooth | Smartooth Co., Ltd. | NBL Light-Induced Fluorescence Caries Detector |
| 14 Dec 2023 | K223470 | C50 | Satelec - Acteon Group | NBL Light-Induced Fluorescence Caries Detector |
| 16 May 2023 | K222560 | BlueCheck Caries Detection & Monitoring | Incisive Technologies Pty Ltd | LFC Caries Detection Device |
| 16 Sep 2022 | K221249 | L1P-1F (TRIOS 5) | 3Shape Trios | NBL Light-Induced Fluorescence Caries Detector |
| 29 Apr 2022 | K213482 | TIA Tip, Cariosity, Transillumination Accessory Tip | D4D Technologies, LLC | NTK Light Transmission Caries Detector |
| 29 Mar 2021 | K200601 | LumiCare Caries Diagnostic Rinse | GreenMark Biomedical Inc. | LFC Caries Detection Device |
| 2 Jul 2020 | K183471 | IC-WHCD100 (Inspire) | Good Doctors Co., Ltd. | NBL Light-Induced Fluorescence Caries Detector |
| 20 Mar 2020 | K193659 | iTero Element 5D | Align Technology, Inc. | NTK Light Transmission Caries Detector |
| 11 Mar 2020 | K193447 | Vista Dyes | Inter-Med/Vista Dental Products | LFC Caries Detection Device |
| 23 Nov 2019 | K182712 | DEXIS CariVu 3-in-1 by KaVo | Kaltenbach & Voigt GmbH | NTK Light Transmission Caries Detector |
| 3 May 2018 | K171007 | Fluorescence Mode | Carl Zeiss Suzhou Co., Ltd. | NBL Light-Induced Fluorescence Caries Detector |
| 22 Nov 2017 | K172007 | CamX Triton HD Proxi Head | Duerr Dental AG | NTK Light Transmission Caries Detector |
| 11 Sep 2017 | K170822 | Electronic Caries Detector | Ortek Therapeutics, Inc. | NBL Light-Induced Fluorescence Caries Detector |
| 27 Jan 2016 | K150672 | VistaCam iX Proof | Durr Dental AG | NBL Light-Induced Fluorescence Caries Detector |
| 24 Sep 2013 | K123402 | DIAGNOCAM | Kaltenbach & Voigt GmbH | NTK Light Transmission Caries Detector |
| 12 Mar 2013 | K121685 | SOPROCARE | Satelec - Acteon Group | NBL Light-Induced Fluorescence Caries Detector |
| 26 Oct 2012 | K112139 | THE CANARY SYSTEM | Quantum Dental Technologies, Inc. | NBL Light-Induced Fluorescence Caries Detector |
| 2 Mar 2012 | K111423 | CS 1600 INTRAORAL CAMERA | Carestream Health, Inc. | NBL Light-Induced Fluorescence Caries Detector |
| 17 May 2011 | K111321 | REMOTE VIEW SOFTWARE | Cariescan , Ltd. | NBL Light-Induced Fluorescence Caries Detector |
| 11 Mar 2011 | K102821 | DISCOVRED | Phoenix Dental, Inc. | LFC Caries Detection Device |
| 23 Apr 2010 | K093705 | FUORECAM | Therapeutic Technologies, Inc. | NBL Light-Induced Fluorescence Caries Detector |
| 13 Jan 2010 | K092583 | SOPROLIFE | Satelec - Acteon Group | NBL Light-Induced Fluorescence Caries Detector |
| 15 Dec 2009 | K090598 | CARIESCAN PRO | Cariescan , Ltd. | NBL Light-Induced Fluorescence Caries Detector |
| 18 Aug 2009 | K090169 | SPECTRA FLUORESCENCE CARIES DETECTION DEVICE | Duerr Dental SE | NBL Light-Induced Fluorescence Caries Detector |
| 10 Sep 2007 | K071429 | TI2200 TRANSILLUMINATION CABLE | Sybron Dental Specialties | NTK Light Transmission Caries Detector |
| 30 Mar 2007 | K063321 | D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138 | Neks Technologies, Inc. | NBL Light-Induced Fluorescence Caries Detector |
| 8 Feb 2007 | K062961 | MICROLUX TRANSILLUMINATOR | Addent, Inc. | NTK Light Transmission Caries Detector |
| 7 Apr 2006 | K060330 | SEE-IT CARIES DETECTOR | Ronvig Dental Mfg. A/S | LFC Caries Detection Device |
| 8 Feb 2006 | K060080 | DIAGNODENT 2190 WITH PERIODONTAL PROBE | KaVo Dental GmbH | NTK Light Transmission Caries Detector |
| 21 Oct 2005 | K051909 | DIAGNODENT | Kavo America | NBL Light-Induced Fluorescence Caries Detector |
| 2 Aug 2005 | K042394 | DIAGNODENT PERIO TIP (ACCESSORY) | Kavo America | NBL Light-Induced Fluorescence Caries Detector |
| 28 Apr 2005 | K043156 | D-CARIE, MODEL N121-M1 | Neks Technologies, Inc. | NBL Light-Induced Fluorescence Caries Detector |
| 29 Dec 2004 | K043068 | DIFOTI USB 2.0 SYSTEM | Electro-Optical Sciences, Inc. | NTK Light Transmission Caries Detector |
| 24 Jun 2004 | K040063 | INSPEKTOR PRO | Inspektor Dental Care BV | NBL Light-Induced Fluorescence Caries Detector |