Surgical devices · 21 CFR 872 Subpart E
Dental Operating Light
FDA device type “Light, Operating, Dental”.
- Companies listing it
- 7259 makers
- Brands and models
- 164
- 510(k) clearances
- 230 in five years
- FDA name
- Light, Operating, Dental
510(k) clearances per year, 1976–2026
Companies that list EAZ
72 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentsply Sirona, Inc. | United States | Maker | — | 148 | 2026 |
| Dentis Co., Ltd. | South Korea | Maker | LUVIS-C100 Series · LUVIS-C200 Series · LUVIS-C300 Series · LUVIS-C400 Series · +4 | 37 | 2026 |
| Megagen Implant Co., Ltd. | South Korea | Maker | Dental Light, ML200 | 30 | 2026 |
| Foshan COXO Medical Instrument Co., Ltd. | China | Maker | Dental Operating Lights; CX249-21; CX249-22; CX249-23; CX249-24 | 6 | 2025 |
| Cefla S.C. | Italy | Maker | VENUS PLUS CL MCT; VENUS PLUS CL SCT; VENUS PLUS CL SCT COMPOSITE; VENUS PLUSCL MCT VIEW · VENUS PLUS E-Led; VENUS PLUS SCT; VENUS PLUS SCT COMPOSITE; VENUS PLUS MCT VIEW · VENUS PLUS L; VENUS PLUS TML-L; VENUS PLUS CL-L; VENUS PLUS CL-M · VENUS PLUS WM SCT; VENUS PLUS WM SCT COMPOSITE; VENUS PLUS WM MCT; VENUS PLUS WM MCT VIEW · +1 | 15 | 2026 |
| Firstar Dental Company | United States | Maker | — | 3 | 2026 |
| Dentalez, Inc. | United States | Maker | CORE Light · Simplicity LED Light · Simplicity Light | 9 | 2026 |
| Den-Mat Holdings, LLC | United States | Maker | Vizilite TBlue | 8 | 2026 |
| Alliage S/A Industrias Medico Odontologica | Brazil | Maker | E-DU Dental Light · Persus L Dental Light · Persus LED Dental Light · Persus Piso Dental Light · +20 | 3 | 2024 |
| Lakong Medical Devices Co., Ltd. | China | Maker | TPC Operatory Light | 2 | 2026 |
| A-dec, Inc. | United States | Maker | A-dec 374L LED Dental Lt, Central Cabinet Mt · A-dec 375L LED Dental Lt, Wall/Side Cabinet Mt · A-dec 376L LED Dental Lt, Ceiling Mt · A-dec 377L LED Dental Lt, Track Mt · +19 | 68 | 2022 |
| Planmeca Oy | Finland | Maker | Planmeca SingLed · Planmeca Solanna | 25 | 2023 |
| Midmark Corporation | United States | Maker | MIDMARK | 7 | 2025 |
| KaVo Dental GmbH | Germany | Maker | Dental Operating Lights · 108.2700 - KaVoLUX 540 LED | 2 | 2021 |
| AIOBIO Co., Ltd. | South Korea | Maker | LINKDENS VU · Qrayview pro | 2 | 2024 |
| Olsen Indústria E Comércio S.A. | Brazil | Maker | LIGHT, OPERATING, DENTAL | 2 | 2022 |
| DCI International LLC | United States | Maker | Dental LED Light | 1 | 2025 |
| Shenzhen Rogin Medical Co., Ltd. | China | Maker | Infinity Endo Curing Light · LED Curing light | 1 | 2025 |
| Guangzhou Ajax Medical Equipment Co., Ltd. | China | Maker | LED Dental Light(model: Amber, Amber II, Pebble, Pebble II, Hubble, Hubble II, Leo, Libra, Whale) | 1 | 2026 |
| Dental Monitoring | France | Maker | LED Adapter | 1 | 2024 |
| Aseptico, Inc. | United States | Maker | ALU-40LED - LIGHT PORTABLE LED OPERATORY · ALU-40LED-CF - LIGHT PORTABLE LED OPERATORY 6520-01-600-8241 · ALU-40MOM - LIGHT PORTABLE LED OPERATORY MOM · ALU-40MOM - LIGHT PORTABLE LED OPERATORY W/STAND MOM | 17 | 2015 |
| Addent, Inc. | United States | Maker | Rite-Lite · Rite-Lite 2 · Rite-Lite PRO | 7 | 2019 |
| Takara Belmont Corporation | Japan | Maker | Belmont | 7 | 2017 |
| Dxm Co., Ltd. | South Korea | Maker | D6 · MULTIPLE names and models | 6 | 2020 |
| Beaverstate Dental, Inc. | United States | Maker | CLX-110 · CLX-220 · FL-3000 | 2 | 1995 |
| Dental Technologies, Inc. | United States | Maker | — | 2 | 2013 |
| Manufacturera Dental Continental | Mexico | Maker | MDC DENTAL OPERATING LIGHT | 2 | 2001 |
| Silfradent srl | Italy | Maker | SUNSHINE S3S EVO BR · SUNSHINE S3S EVO SP · SUNSHINE S3S EVO SS | 1 | 2009 |
| Proma, Inc. | United States | Maker | DARAY BY PROMA | 1 | 1998 |
| Ergonomic Products, Inc. | United States | Maker | Aurora · FastTrack | 1 | 2014 |
| Safari Dental, Inc. | Canada | Maker | REFLECTED LIGHT | 1 | 2010 |
| Shenzhen Denco Medical Co Ltd | China | Maker | LED Curing light | — | — |
| Beyes Dental Inc | Canada | Maker | Beyes Dental Light | — | — |
| J. Morita MFG Corp. | Japan | Maker | FEEL 21 DENTAL OPERATING LIGHT · LUNA-VUE DENTAL OPERATING LIGHT | — | — |
| Henan Baistra Medical Devices Limited | China | Maker | Dental Operating Light | — | — |
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | Dental Operating Light (lamp) | — | — |
| Gavin Biotechnology Co.,ltd | China | Maker | Ultrasonic Tooth Scaler | — | — |
| Dongguan Wanjin Industrial Co., Ltd | China | Maker | Dental Light | — | — |
| Summit Dental Systems LLC. | United States | Maker | Viulux LED Light II | — | — |
| Mastercraft Dental Co. of Texas | United States | Maker | Polaris LED Light | — | — |
| Chuan Fu Medical Instrument Co., Ltd | Taiwan | Maker | M-56 LED Operating Light · M-66 LED Operating Light · M-68 LED Operating Light | — | — |
| Dhef Inc. | Taiwan | Maker | — | — | — |
| FARO S.p.A. | Italy | Maker | E72 · EDI S UL · EDI TS UL · EVA · +2 | — | — |
| Shanghai Greeloy Industry Co., Ltd | China | Maker | DENTAL OPERATION LIGHT | — | — |
| Ascentcare Dental Products | United States | Maker | HyperLUX | — | — |
| Dntlworks Equipment Corp. | United States | Maker | DNTLworks ProBrite | — | — |
| DTE Oregon, Inc | United States | Maker | 9040 Operatory Light, 9070, Dental Operatory Light, 9080 Dental Operatory Light | — | — |
| MedFruition Electronics Technology Co Ltd | China | Maker | Dental Operating Light, model: LED light Plus · Dental Operating Light, model: Niceday, SR1, SL6, LED-5, IL-1, DCR-1, DCR-2, DCR-4K, LED-10,IL-480,DCR-480 · Mechanical Arm for Dental Operating Light,model: A1 | — | — |
| Oralkleen Inc. | United States | Maker | ORALKLEEN | — | — |
| Sinol Dental Limited | China | Maker | Dental Light | — | — |
| DOIFF Co., Ltd. | South Korea | Maker | Aurora / X9, X5, X5 Plus · ML100 / ML100A, ML100B | — | — |
| Dentozone Corporation | South Korea | Maker | eBite3S Blue Light | — | — |
| Kuang Yeu Co. Ltd | Taiwan | Maker | Kuang Yeu | — | — |
| Xenosys Co Ltd | South Korea | Maker | XDL4 | — | — |
| Aopu Lighting (Jinyun) Co., Ltd. | China | Maker | Dental Curing Light-CTBL-N1, CTBL-N2, CTBL-N3 | — | — |
| Forefront (Xiamen) Medical Devices Co., Ltd. | China | Maker | LED Adapter | — | — |
| Dexta Corporation | United States | Maker | — | — | — |
| EPDENT Co., Ltd. | South Korea | Maker | — | — | — |
| whr Hossinger Kunststofftechnik GmbH | Germany | Maker | — | — | — |
| Dentamerica | United States | Repacker / relabeler | CELUX | 4 | 2010 |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | TPC LED Dental Light | 3 | 2007 |
| Boyd Industries, Inc. | United States | Manufacturer | C210 · C300 LED Examination Light · C500 Camera Examination Light System · C510 LED Examination Light · +6 | 1 | 2002 |
| KaVo North America | United States | Lister | Pelton & Crane - Helios 1800 Light · Pelton & Crane - Helios 3000 Light · Pelton & Crane - Light Fantastic II | 1 | 2017 |
| Wuxi Lyusmile Imp and Exp Co.,ltd | China | Private-label distributor | DENTAL LIGHT · led curing light | — | — |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | DENTQ | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | JMU Dental LED Light | — | — |
| Patterson Companies, Inc. | United States | Foreign exporter | Patterson Dental Operating Light | — | — |
| Flight Dental Systems USA Inc. | United States | Repacker / relabeler | Flight Quantum Surgical Light · IRIS LED, Torch LED, iView LED/Camera · Polaris LED | — | — |
| W.H. Holden Inc. DBA H & H Company | United States | Contract manufacturer | LIGHT · OPERATING | — | — |
| Ads Dental System Inc. | United States | Remanufacturer | LED Dental Light(model: Amber, Amber II, Pebble, Pebble II, Hubble, Hubble II, Leo, Libra, Whale) | — | — |
| Toyo Medical Co. | United States | Repacker / relabeler | Toyo Medical Co | — | — |
| FedEx Supply Chain, Inc. | United States | Repacker / relabeler | Gore | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 19 Nov 2007 | K072309 | MICROLUX/BLU | Addent, Inc. |
| 4 Apr 2005 | K041614 | MICROLUX DL | Addent, Inc. |
| 22 Nov 2004 | K033033 | VIZILITE-BLUE ORAL EXAM KIT | Trylon Corp. |
| 16 Mar 2001 | K003995 | SPECULITE/ORALLITE | Trylon Corp. |
| 26 Jan 1994 | K926081 | DENTAL LIGHT | Mdt Corp., Inc. |
| 10 Dec 1993 | K935390 | SIROLUX FANTASTIC | Pelton & Crane |
| 23 Nov 1993 | K925629 | ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT | Den-Tal-Ez Mfg Co., Inc. |
| 21 Dec 1992 | K923462 | DELIGHT | Planmeca USA, Inc. |
| 30 Oct 1991 | K912997 | MINIFLEX AND PERSONAL UNIT | Dabi-Atlante America Corp. |
| 30 Oct 1991 | K912142 | MICRONAIRE ISO-HOOD MAX 5UV | Micronaire Corp. |
| 17 Sep 1990 | K902685 | DEFIANCE MODEL FUS 336 | Defiance Electronics, Inc. |
| 7 Sep 1989 | K894059 | ISOLIGHT | Eurodent, Inc. |
| 14 Jul 1989 | K893044 | A-DEC DENTAL LIGHT | A-dec, Inc. |
| 2 Jun 1989 | K891216 | DENTAL EQUIPMENT PROTECTION DEVICES | Pro-Safe Professional Linens, Inc. |
| 17 Mar 1989 | K884223 | DENTAL LAMP HANDLE COVER | Steri-Shield Products, Inc. |
| 19 Jan 1988 | K874374 | THE WOOG ORATEST | Woog Intl. |
| 29 Sep 1986 | K863019 | F-11 REFLECTOR / F-II STANDARD REFLECTOR | Sds Dental, Inc. |
| 2 Mar 1984 | K832919 | OPTI-BEAM IV | Dentsply Intl., Inc. |
| 4 Aug 1980 | K801683 | LUNA-VUE DENTAL OPERATING LIGHT | Pacific Dental Corp. |
| 22 Oct 1979 | K790984 | KLIP-LITE | Innovators, Inc. |
| 17 Jan 1978 | K772351 | DENTAL LIGHT | Chemetron Dental Products |
| 15 Jul 1977 | K771249 | JOY LIGHT | M.D. Intl., Inc. |
| 5 Oct 1976 | K760707 | RITTER STARLIGHT DENTAL OPERATING LIGHT | Ritter Co. |
Official records: FDA product classification for EAZ · 21 CFR 872.4630.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026