Dental operating lights: manufacturers and brands
95 companies make or specify dental operating lights among the 126 that list one with FDA, under 252 brand and model names. FDA has issued 51 510(k) clearances in this category, 0 of them in the last five years.
510(k) clearances per year, 1976–2026
Dental operating light 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 |
| 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 |
| Sybron Dental Specialties | United States | Maker | Light Guides for Curing Lights · Dragonfly ErgoZoom · Dragonfly NEO · Dragonfly PRO · +8 | 203 | 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 |
| Stryker | United States | Maker | DENTAL HEADLIGHT | 33 | 2024 |
| Changzhou Sifary Medical Technology Co., Ltd. | China | Maker | Surgical Headlight, Wireless Z, Lux-SFT, Wireless Z+ | 4 | 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 | Fiber optic/Dental delivery unit · 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 |
| Foshan SOCO Precision Instrument Co.,Ltd. | China | Maker | Medical Headlight · model:SCML05,SCML06 | 1 | 2024 |
| 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 |
| Zumax Medical Co., Ltd. | China | Maker | HEADLIGHTS · HL8000 HEADLIGHT · HL8200 HEADLIGHT · HL8260 HEADLIGHT · +2 | 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 |
| Zimmer Inc | United States | Maker | LIGHT CABLE | 14 | 2001 |
| 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 |
| Apoza Enterprise Co., Ltd. | Taiwan | Maker | Light, fiber Optic, Dental | 5 | 2007 |
| Dentlight, Inc. | United States | Maker | iZoom | 3 | 2019 |
| 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 |
| B. Ali Impex | Pakistan | Maker | BALI · DOCTOR NICE | — | — |
| 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 | — | — |
| Qibei Technology Co., Limited | China | Maker | Dental operating lamp · LD01,LD02,LD03,LD05,LD06 | — | — |
| Teleflex | United States | Maker | LIGHT · MULTIPLE SURGICAL HEADLIGHT LIGHTS · SURGICAL HEADLIGHT | — | — |
| one day dental partner | South Korea | Maker | kage Light | — | — |
| Henan Baistra Medical Devices Limited | China | Maker | Dental Operating Light | — | — |
| HILBRO International (Pvt) Ltd. | Pakistan | Maker | Hilbro Intl surgical headlight light | — | — |
| Hangzhou Wise Medical Device Co.,Ltd | China | Maker | Dental Operating Light (lamp) | — | — |
| Gavin Biotechnology Co.,ltd | China | Maker | Ultrasonic Tooth Scaler | — | — |
| Dentech Corp. | Japan | Maker | Dentech Corporation | — | — |
| Dongguan Wanjin Industrial Co., Ltd | China | Maker | Optic Light · Dental Light | — | — |
| Summit Dental Systems LLC. | United States | Maker | Viulux LED Light II | — | — |
| Mastercraft Dental Co. of Texas | United States | Maker | Polaris LED Light | — | — |
| Hexamed Pvt Ltd | Pakistan | Maker | Dental Surgical Headlight | — | — |
| Chuan Fu Medical Instrument Co., Ltd | Taiwan | Maker | M-56 LED Operating Light · M-66 LED Operating Light · M-68 LED Operating Light | — | — |
| Greens Surgicals Private Limited | India | Maker | GREENS | — | — |
| Dhef Inc. | Taiwan | Maker | FIBER OPTIC · LIGHT | — | — |
| 麦迪卡有限公司 MedicNRG Ltd | Israel | Maker | LIGHT, FIBER OPTIC, DENTAL · LumiNRG | — | — |
| 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 | — | — |
| Endonest Medical Systems LLP | India | Maker | Light, Fiber Optic, EndoNest FOC, EndoNest Lights , EndoNest Cables , EndoNest All Type Cables | — | — |
| 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 | — | — |
| Quality Aspirators | United States | Maker | Fiber Optic Light · Fiber Optic Headlight | — | — |
| Sinol Dental Limited | China | Maker | Dental Light | — | — |
| Sunoptic Technologies LLC | United States | Maker | BRAND · Cuda · Customer brand · FIBEROPTIC HEADLIGHT SYSTEM · +1 | — | — |
| Denbur Inc | United States | Maker | Light-Tip | — | — |
| DOIFF Co., Ltd. | South Korea | Maker | Aurora / X9, X5, X5 Plus · ML100 / ML100A, ML100B | — | — |
| Dentozone Corporation | South Korea | Maker | eBite3S Blue Light | — | — |
| Illuco Co, LTD | South Korea | Maker | IHL-2000 | — | — |
| Kuang Yeu Co. Ltd | Taiwan | Maker | Kuang Yeu | — | — |
| Bryant Medical Ltd | United Kingdom | Maker | Ignis Headlight System | — | — |
| Kmi Imi Group / Dba Innovative Med, Inc. | United States | Maker | THERAGLOW SMILE MACHINE | — | — |
| MedDev Corporation | United States | Maker | SAME (OR "MEDDEV SURGICAL HEADLIGHT · " "MEDDEV SURGICAL HEADL | — | — |
| Xenosys Co Ltd | South Korea | Maker | XDL4 · L2SX5 | — | — |
| Alira Medical Devices LLC | United States | Maker | LIGHT, FIBER OPTIC, DENTAL | — | — |
| Aopu Lighting (Jinyun) Co., Ltd. | China | Maker | Dental Curing Light-CTBL-N1, CTBL-N2, CTBL-N3 | — | — |
| Chamfond Biotech Co., Ltd | China | Maker | Headlight | — | — |
| Elite Precision Instruments Company LLC | United States | Maker | Epic LED | — | — |
| Forefront (Xiamen) Medical Devices Co., Ltd. | China | Maker | LED Adapter | — | — |
| Jiangsu Keling Medical Appliances Co.,Ltd. | China | Maker | operation light(Model:KL-LED.STR78 series, KL-LED.DTR78 series KL-LED.D78 series, KL-LED.STZ4 series, KL-LED.STZ5series) | — | — |
| OpInstruments GmbH | Germany | Maker | Medical Headlight | — | — |
| Snap On Optics | United States | Maker | Snap On Loupe Light | — | — |
| Taizhou Huangyan Guanhong Plastic Steel Products Factory | China | Maker | Light Handle Covers | — | — |
| Dexta Corporation | United States | Maker | — | — | — |
| EPDENT Co., Ltd. | South Korea | Maker | — | — | — |
| evonos GmbH & Co. KG | Germany | Maker | — | — | — |
| Keeler Ltd | United Kingdom | Maker | — | — | — |
| RZ Medizintechnik GmbH | Germany | Maker | — | — | — |
| whr Hossinger Kunststofftechnik GmbH | Germany | Maker | — | — | — |
| 鲁道夫医疗有限公司Rudolf Medical GmbH+Co.KG | Germany | Maker | — | — | — |
| Young Innovations Inc | United States | Contract manufacturer | — | 23 | 2025 |
| Essential Dental Systems, Inc. | United States | Repacker / relabeler | Endo CSV LED Light | 15 | 2023 |
| Reliance Orthodontic Products, Inc. | United States | Contract manufacturer | POWER SLOT | 32 | 2021 |
| Dent Zar, Inc. | United States | Repacker / relabeler | DENTAL CURING LIGHT | 12 | 1996 |
| Dentamerica | United States | Repacker / relabeler | LITEX · CELUX | 4 | 2010 |
| Tpc Advanced Technology, Inc. | United States | Repacker / relabeler | TPC Fiber Optic System · TPC LED Dental Light | 3 | 2007 |
| Hager Worldwide, Inc. | United States | Manufacturer | — | 2 | 2005 |
| 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 |
| KARL STORZ SE & Co. KG | Germany | Contract manufacturer | Headlight | 1 | 1998 |
| Olympus Corporation | Japan | Foreign exporter | — | 1 | 2007 |
| 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 | — | — |
| Aspen Surgical Products | United States | Contract manufacturer | Symmetry Surgical | — | — |
| 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 | FIBER OPTIC · LIGHT · OPERATING | — | — |
| Unisource Shanghai Ltd. | China | Foreign exporter | LED Headlight System | — | — |
| 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 | — | — |
| Andau Medical Inc. | Canada | Lister | Admetec Butterfly S-EVO · Admetec Orchid · Admetec Orchid Ergo · Admetec Orchid-F · +1 | — | — |
| FedEx Supply Chain, Inc. | United States | Repacker / relabeler | Gore | — | — |
| Black & Black Surgical Inc | United States | Repacker / relabeler | Headlight | — | — |
| Arvato SE | Germany | Repacker / relabeler | Head light | — | — |
| BFW, Inc. | United States | Repacker / relabeler | KITSILANO LED Headlight | — | — |
| Rudolf Riester GmbH & Co KG | Germany | Repacker / relabeler | K-L.E.D Surgical Headlight | — | — |
| Spiggle & Theis Medizintechnik GmbH | Germany | Repacker / relabeler | Light Surgical Headlight | — | — |
| INVIDIA Medical GmbH u CO KG | Germany | Repacker / relabeler | — | — | — |
| Microsurgery Instruments, Inc. | United States | Repacker / relabeler | — | — | — |
| Tekno-Medical Optik-Chirurgie GmbH | Germany | Manufacturer | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Where dental operating lights 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 |
|---|---|---|---|---|
| Dental Operating LightEAZ | 1 | 872.4630 | 59 | 23 |
| Surgical Headlight LightEBA | 1 | 872.4630 | 29 | 10 |
| Dental Fiber Optic LightEAY | 1 | 872.4620 | 13 | 18 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 19 Nov 2007 | K072309 | MICROLUX/BLU | Addent, Inc. | EAZ Dental Operating Light |
| 12 Feb 2007 | K070287 | PS SERIES WITH FIBER LIGHT GUIDE AND HEADLIGHT, MODELS PS200, PS250, PS500 | Photonic Optische Gerate GmbH & Cokg | EBA Surgical Headlight Light |
| 4 Apr 2005 | K041614 | MICROLUX DL | Addent, Inc. | EAZ Dental Operating Light |
| 22 Nov 2004 | K033033 | VIZILITE-BLUE ORAL EXAM KIT | Trylon Corp. | EAZ Dental Operating Light |
| 16 Mar 2001 | K003995 | SPECULITE/ORALLITE | Trylon Corp. | EAZ Dental Operating Light |
| 5 Sep 1995 | K953192 | MODEL A15-103 | Beaverstate Dental, Inc. | EAY Dental Fiber Optic Light |
| 5 Sep 1995 | K953191 | MODEL A15-101 | Beaverstate Dental, Inc. | EAY Dental Fiber Optic Light |
| 26 Jan 1994 | K926081 | DENTAL LIGHT | Mdt Corp., Inc. | EAZ Dental Operating Light |
| 26 Jan 1994 | K935718 | JEDENTAL VLC DENTAL CURING LIGHT | Jedental Co., Inc. | EAY Dental Fiber Optic Light |
| 10 Dec 1993 | K935390 | SIROLUX FANTASTIC | Pelton & Crane | EAZ Dental Operating Light |
| 23 Nov 1993 | K925629 | ACCESSORY TO IMPROVED DENTAL OPERATING LIGHT | Den-Tal-Ez Mfg Co., Inc. | EAZ Dental Operating Light |
| 21 Dec 1992 | K923462 | DELIGHT | Planmeca USA, Inc. | EAZ Dental Operating Light |
| 16 Oct 1992 | K923949 | SYLVAN DENTAL HEADLIGHT SYSTEM | Sylvan Medical Fiberoptics | EBA Surgical Headlight Light |
| 30 Oct 1991 | K912997 | MINIFLEX AND PERSONAL UNIT | Dabi-Atlante America Corp. | EAZ Dental Operating Light |
| 30 Oct 1991 | K912142 | MICRONAIRE ISO-HOOD MAX 5UV | Micronaire Corp. | EAZ Dental Operating Light |
| 17 Sep 1990 | K902685 | DEFIANCE MODEL FUS 336 | Defiance Electronics, Inc. | EAZ Dental Operating Light |
| 7 Sep 1989 | K894059 | ISOLIGHT | Eurodent, Inc. | EAZ Dental Operating Light |
| 14 Jul 1989 | K893044 | A-DEC DENTAL LIGHT | A-dec, Inc. | EAZ Dental Operating Light |
| 22 Jun 1989 | K893458 | FIBEROPTIC HEADLIGHT SYSTEM | Cuda Products Co. | EBA Surgical Headlight Light |
| 2 Jun 1989 | K891216 | DENTAL EQUIPMENT PROTECTION DEVICES | Pro-Safe Professional Linens, Inc. | EAZ Dental Operating Light |
| 17 Mar 1989 | K884223 | DENTAL LAMP HANDLE COVER | Steri-Shield Products, Inc. | EAZ Dental Operating Light |
| 19 Jan 1988 | K874374 | THE WOOG ORATEST | Woog Intl. | EAZ Dental Operating Light |
| 3 Aug 1987 | K871816 | STRYKERSCOPE TM/ORTHOSCOPE TM/STRYKER MINISCOPE TM | Stryker | EAY Dental Fiber Optic Light |
| 29 Sep 1986 | K863019 | F-11 REFLECTOR / F-II STANDARD REFLECTOR | Sds Dental, Inc. | EAZ Dental Operating Light |
| 6 Mar 1986 | K854646 | VEGA DENTAL OPERATING LIGHT | Alpine Dental Equipment Co. | EBA Surgical Headlight Light |
| 2 Aug 1984 | K842515 | SURGICAL HEADLIGHT | Good-Lite Co. | EBA Surgical Headlight Light |
| 31 Jul 1984 | K842358 | ISOLIGHT | Planmeca USA, Inc. | EBA Surgical Headlight Light |
| 2 Mar 1984 | K832919 | OPTI-BEAM IV | Dentsply Intl., Inc. | EAZ Dental Operating Light |
| 12 Aug 1983 | K831976 | POWER OPTIC | Ritter Co. | EAY Dental Fiber Optic Light |
| 11 Aug 1983 | K831824 | DENTAL ELECTRONIC/S.B.R TRADING BU HAND | Silverman'S | EAY Dental Fiber Optic Light |
| 28 Sep 1982 | K822265 | FIBEROPTIC LIGHT SOURCE W/RELATED ITEMS | Kelleher Corp. | EBA Surgical Headlight Light |
| 5 May 1982 | K820907 | DENTISCOPE | Chayes Virginia, Inc. | EAY Dental Fiber Optic Light |
| 2 Oct 1981 | K812605 | FIBER OPTIC LIGHT SOURCE I | Venture Technology, Inc. | EAY Dental Fiber Optic Light |
| 10 Feb 1981 | K810117 | HALOGEN HEADLIGHT SYSTEM | Colmed, Ltd. | EBA Surgical Headlight Light |
| 24 Nov 1980 | K802684 | HELIOMAT | Vivadent (Usa), Inc. | EAY Dental Fiber Optic Light |
| 12 Nov 1980 | K802716 | DEN-MAT FIBER OPTIC HALOGEN LIGHT | Den-Mat Corp. | EAY Dental Fiber Optic Light |
| 4 Aug 1980 | K801683 | LUNA-VUE DENTAL OPERATING LIGHT | Pacific Dental Corp. | EAZ Dental Operating Light |
| 21 Jul 1980 | K801592 | FIBER OPTIC HOSE | Lares Manufacturing Co., Inc. | EAY Dental Fiber Optic Light |
| 21 Jul 1980 | K801591 | FIBER OPTIC ILLUMINATOR | Lares Manufacturing Co., Inc. | EAY Dental Fiber Optic Light |
| 20 Nov 1979 | K791771 | ORALUMINATOR III AUTO-LIGHT | Midwest | EAY Dental Fiber Optic Light |