Teeth whitening lights: manufacturers and brands
82 companies make or specify teeth whitening lights among the 111 that list one with FDA, under 218 brand and model names. FDA has issued 12 510(k) clearances in this category, 0 of them in the last five years.
510(k) clearances per year, 1976–2026
Teeth whitening 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 |
|---|---|---|---|---|---|
| Foshan COXO Medical Instrument Co., Ltd. | China | Maker | Teeth Whitening Accelerator; C-Bright, C-Bright Ia | 6 | 2025 |
| Pac-Dent Inc. | United States | Maker | — | 5 | 2022 |
| Denjoy Dental Co., Ltd. | China | Maker | LED WHITENING LIGHT | 1 | 2025 |
| Cavex Holland BV | Netherlands | Maker | Cavex Bite&White · Cavex Bite&White ExSense · Cavex Bite&White StainLess · White Royale Extreme Cleaning Toothpaste · +1 | 26 | 2015 |
| Philips Medical Systems International BV | Netherlands | Maker | Zoom WhiteSpeed Lamp | 16 | 2010 |
| Procter & Gamble | United States | Maker | — | 16 | 2020 |
| CAO Group, Inc. | United States | Maker | Picasso Pro Diode Laser | 13 | 2020 |
| Monitex Industrial Co., Ltd. | Taiwan | Maker | Henry Schein · WE Light Class II | 9 | 2017 |
| Addent, Inc. | United States | Maker | Calset Aluminum Accessory Trays · Calset Composite Warmer | 7 | 2019 |
| Colgate-Palmolive Company | United States | Maker | — | 6 | 2014 |
| Dxm Co., Ltd. | South Korea | Maker | ALADDIN | 6 | 2020 |
| Rolence Ent., Inc. | Taiwan | Maker | crystal ; elitedent | 5 | 2009 |
| Apoza Enterprise Co., Ltd. | Taiwan | Maker | BT COOL;BT COOL (plus) ; BT COOL Easy · LED TURBO | 5 | 2007 |
| Nanova Biomaterials Inc | United States | Maker | — | 5 | 2018 |
| Zhengzhou Huaer Electro-optics Technology Co., Ltd. | China | Maker | Heat Source for Bleaching Teeth · Teeth Whitening lamp/Machine/Light | 1 | 2020 |
| Ronvig Dental Mfg. A/S | Denmark | Maker | EASE-IT | 1 | 2006 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | led light curing unit · LIGHT SOURCE FOR BLEACHING TEETH · Smart Teeth Whitening Device · Teeth Whitening LED Light · +2 | — | — |
| Guangxi Hope Medical Devices Technology Co., Ltd. | China | Maker | Dental Light-Activated Whitening Device XWYL-301A · Dental Light-Activated Whitening Device XWYL-301B · Dental Light-Activated Whitening Device XWYL-301C · Dental Light-Activated Whitening Device XWYL-302BW · +47 | — | — |
| Shenzhen Fortunecome Technology Co.,Ltd. | China | Maker | — | — | — |
| Jiangxi IVISMILE Technology Co.,Ltd | China | Maker | Mini Light 1led/5led;Teeth Whitening Light 8led/16led/32led;Teeth Whitening Led Light 8led/16led/32led; · Plusma Light; Moons, Moonlight; Pola LED mouthpiece; ProLite LED Teeth Whitening Device; Smart Teeth Whitening Light; · Teeth Whitening Lamp; Teeth Whitening Accelerator; Teeth Whitening Mini Light; Teeth Whitening Light; · Teeth Whitening Led Light; Portable Teeth Whitening Light; Smart Teeth Whitening Device; · +2 | — | — |
| Xiamen Yizhou Imp. & Exp. Co., Ltd. | China | Maker | teeth whitening LED light;teeth whitening light; teeth whitening mouth tray LED light;teeth whitening accelerator | — | — |
| Jiangxi Dentalbright Technology Co., Ltd | China | Maker | Plusma Light; Teeth Whitening Light; Teeth whitening Led Light; Portable Teeth Whitening Light; · ProLite LED Teeth Whitening Device, Wireless Dental Instrument · Smart Teeth Whitening Device; Smart Teeth Whitening Light; Teeth Whitening Lamp; Teeth Whitening Accelerator; · Teeth whitening Led Light 8led/16led; Teeth Whitening Mouth Tray Led Light; Teeth Whitening Mouth Tray Light · +1 | — | — |
| Nanchang White Technology Co., Ltd. | China | Maker | Mini Light 1led/5led;Teeth Whitening Light 8led/16led · Plusma Light; Teeth Whitening Light; Teeth Whitening Led Light; Portable Teeth Whitening Light; · ProLite LED Teeth Whitening Device, Wireless Dental Instrument; Smart Teeth Whitening Device; · Smart Teeth Whitening Light; Teeth Whitening Lamp; Teeth Whitening Accelerator; Teeth Whitening Led Light 8led/16led; · +1 | — | — |
| VIS (Shanghai) Technology, Co. Ltd. | China | Maker | ISSA Teeth whitening device | — | — |
| Beaming White LLC | United States | Maker | Futura 2000 · Futura 2400 · Futura Face · Futura Go · +2 | — | — |
| Onuge Personal Care(Guangdong)Manufacturer Group Co., LTD. | China | Maker | Dentiguard LED Teeth whitening Kit | — | — |
| Ekong Technology Co., Limited. | China | Maker | Mini Light 1led/3led /5led;Teeth Whitening Light 8led/16led · Plusma Light; Teeth Whitening Light; Teeth whitening Led Light; Portable Teeth Whitening Light · Smart Teeth Whitening Device; Smart Teeth Whitening Light; Teeth Whitening Lamp; Teeth Whitening Accelerator · Teeth Whitening Mini Light; Teeth Whitening Mouth Tray Led Light; Teeth Whitening Mouth Tray Light | — | — |
| LLRN Personal Care (Shenzhen) Co.,ltd | China | Maker | Smart Teeth Whitening Light, Wireless Teeth Whitening Light · Teeth whitening Led Light 8led/16led, LED Teeth Whitening Device, Smart Teeth Whitening Device, · Teeth whitening Led Light, Portable Teeth Whitening Light, Teeth Whitening Mini Light, Mini Light 1led,5led, · Teeth Whitening Light 8led/16led, Teeth Whitening Lamp, Teeth Whitening Accelerator, · +1 | — | — |
| Jiangxi Ushine Bright Medical Co., Ltd. | China | Maker | Teeth Whitening Light/ Teeth whitening Led Light/ Portable Teeth Whitening Light/ Teeth Whitening Lamp/ · Teeth Whitening Mouth Tray Led Light/ Teeth Whitening Mini Light 1/5 LED; Teeth Whitening Light 8/16/24/32 LED | — | — |
| Aimi Health Technology (Guangdong) Co., Ltd. | China | Maker | HEAT SOURCE FOR BLEACHING TEETH-Teeth Whitening Kit | — | — |
| Changzhou IVORIE Shengmei Packaging Technology Co.Ltd | China | Maker | HEAT SOURCE FOR BLEACHING TEETH (Teeth Whitening Mini Light; Mini Light 1led/5led; · Smart Teeth Whitening Light; Teeth Whitening Lamp) · Teeth whitening Led Light 8led/16ledSmart Teeth Whitening Device; · Teeth whitening Led Light(MD666); Teeth Whitening Mouth Tray Led Light; · +2 | — | — |
| DongGuan Magenta Medical Equipment Co., Ltd. | China | Maker | Magenta Heat Source Bleach | — | — |
| Fuzhou Delphin Bio-tech Co., Ltd. | China | Maker | Teeth whitening light | — | — |
| Heyuan Hey White Technology Co., Ltd. | China | Maker | Oral Device YLX-307i, Teeth Whitening Device, Teeth Whitening Vibration Device · Red Light Therapy Device | — | — |
| Shenzhen YiGuangNian Innovation Technology Co., Ltd. | China | Maker | BE LUCENT STELLAR XPRE170 XPRE137 XPRE067 XPRE153 · Heat Source For Bleaching Teeth-Professional Light Teeth · Professional Light Teeth Whitening Kit XPRE067 XPRE136, Blue light teeth whitening device · Whitening Kit XPRE137; Professional Light Teeth Whitening:XPRE137 · +4 | — | — |
| Huizhou Gold Rose Technology Co.,Ltd | China | Maker | M11 · Oral Red Light Massager | — | — |
| Guangxi Ehall Medical Technology Co.,Ltd | China | Maker | Composite Heater | — | — |
| Shenzhen Balinda Technology Co.,Ltd | China | Maker | Teeth Whitening Light/Teeth Whitening Device | — | — |
| Shenzhen Samo Technology Co.,Limited | China | Maker | Teeth Whitening LED Accelerator Lights,L100,L200,L300,L400,L500,L600,L700,L800,L900 | — | — |
| Dongguan MiQiang Technology Co., Ltd | China | Maker | BE LUCENT STELLAR XPRE170 XPRE137 XPRE067; Heat Source For Bleaching Teeth Professional Light Teeth; · Professional Light stellar; XPRE458,XPRE461-Blue Light Teeth Whitening Device; Whitening Kit, XPRE459 · Professional Light Teeth Whitening Kit XPRE067, Blue light teeth whitening device; Whitening Kit XPRE137; · Professional Light Teeth Whitening: XPRE137; Whitening:XPRE153, XPRE170; Professional Light Teeth; XPRE170P · +1 | — | — |
| Dhef Inc. | Taiwan | Maker | — | — | — |
| GuangDong Roman Technology Co., Ltd | China | Maker | Vibrite Blue, TRI BEAM EDGE | — | — |
| Taizhou Polus Technology Co., Ltd. | China | Maker | BEYOND® II Ultra Whitening Accelerator (BE-818UL) · BEYOND® II Whitening Accelerator (BE-818) · BEYOND® Polus® Advanced Ultra Whitening Accelerator (PLS-868UL) · BEYOND® Polus® Advanced Whitening Accelerator (PLS-868A) · +1 | — | — |
| Xingyue Medical Health Technology (Nanjing) Co., Ltd . | China | Maker | Teeth Whitening Kits | — | — |
| GLO Science, Inc. | United States | Maker | GLO Control · GLO Teeth Whitening Device Kit | — | — |
| Jiangsu Xingsheng Brush Co., Ltd. | China | Maker | — | — | — |
| Magenta Technology International Limited | China | Maker | Teeth Whitening kits · Teeth Whitening Kits, whitening strips | — | — |
| Shanghai Greeloy Industry Co., Ltd | China | Maker | CURING LIGHT | — | — |
| Cometech VN Company Limited | Vietnam | Maker | COMETECH VN | — | — |
| Foshan Ousidun Personal Care Products Co.,Ltd | China | Maker | Teeth Whitening LED Light | — | — |
| Medcodes Healthcare (Shenzhen) Limited | China | Maker | medcodes W10, medcodes W20, medcodes W30, medcodes W40 · Teeth Bleaching Light W1001, W3001, W4002, W4003 · Teeth Whitening Strip WS301, WS401 · W4009,W4019,W4011,W4018,W4010,W4017,W4015,W4016,W4260,W4280 | — | — |
| World Dentists Association America Limited | Hong Kong SAR China | Maker | Teeth Whitening Device | — | — |
| Moon Oral Care, LLC. | United States | Maker | Teeth Whitening Device | — | — |
| Shanghai Shift Electrics Co.,ltd. | China | Maker | — | — | — |
| Shenzhen Mlikang Technology Co., Ltd | China | Maker | Teeth Whitening Led Light M245,M246,M247 | — | — |
| Changzhou Freshday Household Products Corp. Ltd. | China | Maker | HEAT SOURCE FOR BLEACHING TEETH | — | — |
| Hi-P (Xiamen) Precision Plastic Manufacturing Co., | China | Maker | COLGATE OPTIC WHITE PROFESSIONAL | — | — |
| Shenzhen Lunata Technology Co., Ltd | China | Maker | Teeth Whitening Kit M06,M08,M10,M12 | — | — |
| Shenzhen Kaiyan Medical Equipment Co., Ltd | China | Maker | Heat source for bleaching teeth · Teeth Whitening Device (Model: YT-11E) | — | — |
| T33 Dental Inc. | United States | Maker | Rheyo Whitening | — | — |
| DMC Importacao e Exportacao de Equipamentos Ltda | Brazil | Maker | e-light B-US · e-light V-US | — | — |
| Dragon Medical Co.,Ltd | China | Maker | Teeth Whitening | — | — |
| Kmi Imi Group / Dba Innovative Med, Inc. | United States | Maker | INFINITY TEETH WHITENING SYSTEM | — | — |
| Novaalab LLC | United States | Maker | Novoral Care Pro | — | — |
| Shenzhen Ruiyi Business Technology Co., Ltd. | China | Maker | TEETH WHITENING KIT: RP-TW16-2,RP-TW16,RP-TW32 · TEETH WHITENING PEN:RP-TWG3-4 | — | — |
| Shenzhen Youmay Electronics Co., Ltd | China | Maker | HEAT SOURCE FOR BLEACHING TEETH | — | — |
| WUHAN ZJZK TECHNOLOGY CO.,LTD. (aka WUHAN ZJKC TECHNOLOGY CO | China | Maker | LED Whitening Light Models:WW01,WW02,WW03 · Teeth Whitening Device Models:TW01,TW02,TW03 | — | — |
| AndersonBrecon Inc. | United States | Maker | — | — | — |
| Currentbody Ltd. | United Kingdom | Maker | CurrentBody LED Teeth Whitening Device | — | — |
| Dongguan Suscong Healthcare Co., Ltd. | China | Maker | Teeth Whitening Kit | — | — |
| Gigaalaser company ltd. | China | Maker | Medical Diode Laser Systems | — | — |
| Grandee Electric Appliance (Shenzhen) Limited | China | Maker | HEAT SOURCE FOR BLEACHING TEETH | — | — |
| Shanghai Wonderful Opto Electrics Tech Co Ltd | China | Maker | Diode Laser System | — | — |
| Spa Dent Inc. | Canada | Maker | Spa Dent Red + Blue Light Whitening Kit | — | — |
| TECNO-GAZ S.p.A. | Italy | Maker | Swan-I | — | — |
| White Smile GmbH | Germany | Maker | flash Whitening Lamp | — | — |
| Yamada Electric Vietnam Company Limited | Vietnam | Maker | Crest Light | — | — |
| Zhejiang JOOZENA Medical Technology Co., Ltd. | China | Maker | HeatSourceForBleachingTeethModel:JZA-TWK-1.1;JZA-TWK-1.2;JZA-TWK-1.3 | — | — |
| 怀特爱齿股份有限公司 ホワイトエッセンス株式会社 White Essence Co.,Ltd | Japan | Maker | WE Light Class II | — | — |
| Ever Strong Manufacturing Ltd. | China | Maker | — | — | — |
| Motion Dental Equipment Corp. | Taiwan | Maker | — | — | — |
| Samson Innovation Corp. Ltd. | Hong Kong SAR China | Maker | — | — | — |
| Voco GmbH | Germany | Foreign exporter | Caps Warmer | 117 | 2026 |
| Ivoclar Vivadent, AG | United States | Contract manufacturer | VivaStyle Whitening LED Kit | 94 | 2026 |
| Park Dental Research Corp | United States | Contract manufacturer | Teeth Whitening Light; Teeth whitening Led Light; Portable Teeth Whitening Light;; ProLite LED Teeth Whitening Device | 8 | 2026 |
| Dentamerica | United States | Repacker / relabeler | EVERBRITE | 4 | 2010 |
| Ranir, LLC | United States | Foreign exporter | — | 2 | 2011 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | DENTQ | — | — |
| Jmu Dental, Inc. | United States | Repacker / relabeler | LED Whitening Light, LED Curing Light | — | — |
| LG H&H Co., Ltd. | South Korea | Foreign exporter | PERIOE Thera-White Instant Whitening LED Light | — | — |
| Ortho Dental Lab, LLC | United States | Manufacturer | SmileSet Premium Whitening Kit · SmileSet Wireless Whitening Light | — | — |
| Foreo Inc. | United States | Lister | ISSA Teeth Whitening Device | — | — |
| Xplora USA LLC | United States | Manufacturer | Six Month Smiles | — | — |
| ATOMO Dental, Inc. | United States | Repacker / relabeler | LED Whitening Light, LED Curing Light | — | — |
| WSD Labs Usa Inc. | United States | Repacker / relabeler | Plusma Light; Teeth Whitening Light; Teeth whitening Led Light; Portable Teeth Whitening Light; · Smart Teeth Whitening Device; Smart Teeth Whitening Light; Teeth Whitening Lamp; Teeth Whitening Accelerator; · Teeth whitening Led Light 8led/16led; Teeth Whitening Mouth Tray Led Light; · Teeth Whitening Mini Light; Mini Light 1led/5led;Teeth Whitening Light 8led/16led; · +2 | — | — |
| Cordica Medical (Formally Team Technologies, Inc) | United States | Contract manufacturer | Optic White Professional | — | — |
| Shenzhen Mold and Manufacturing Co Ltd | China | Contract manufacturer | Evoke · Futura 2400 | — | — |
| Gurunanda LLC | United States | Contract manufacturer | MENTADENT DAZZLE BRIGHT | — | — |
| HiSmile Pty Ltd | Australia | Foreign exporter | Hismile LED Teeth Whitening Device, Sona Teeth Whitening Device (new), Smilehero Teeth Whitening Kit · Hismile VIO405 Device, Hismile Professional Accelerator | — | — |
| Oravance Wellness LLC. | United States | Lister | SNOW DIAMOND SERIES WIRED WHIITENING DEVICE · SNOW DIAMOND SERIES WIRELESS WHIITENING DEVICE | — | — |
| Beyond International Inc. | United States | Manufacturer | — | — | — |
| Ryder Integrated Logistics, INC | United States | Repacker / relabeler | — | — | — |
| STS (Guangzhou) Trading Limited Company | China | Foreign exporter | Teeth whitening Kits | — | — |
| IDS S.p.a. | Italy | Foreign exporter | Swan-I | — | — |
| Shanghai Lansheng Light Industrial Products Imp. & Exp. Corp | China | Foreign exporter | — | — | — |
| Accupac, LLC | United States | Contract manufacturer | — | — | — |
| Joicom Corporation | United States | Lister | — | — | — |
| Mainline Medical Dental Supply | Canada | Foreign exporter | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Swedent Dental Wholesale Group | United States | Repacker / relabeler | — | — | — |
| Unicskin Sl | Spain | Foreign exporter | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Where teeth whitening lights are made
China54United States14Taiwan5Vietnam3Netherlands2Brazil2Germany2Hong Kong SAR China2Guatemala1United Kingdom1
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 |
|---|---|---|---|---|
| Heat Source for Bleaching TeethEEG | 1 | 872.6475 | 82 | 12 |
Recent clearances
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 27 Nov 2012 | K122725 | TANDA PEARL, ULTRAWYTE, PEARL | Syneron Beauty | EEG Heat Source for Bleaching Teeth |
| 12 Jan 2012 | K110888 | ABSOLUTE WHITE LIGHT | Dr. Fresh, Inc. | EEG Heat Source for Bleaching Teeth |
| 20 Feb 2007 | K063704 | BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101 | Beks Incorporated | EEG Heat Source for Bleaching Teeth |
| 18 Oct 2005 | K052040 | QUICKSMILE | Cosmetic Dental Materials, Inc. | EEG Heat Source for Bleaching Teeth |
| 8 Nov 2004 | K042153 | SOUTH BEACH SMILE LIGHT WHITENING SYSTEM | Dentovations, Inc. | EEG Heat Source for Bleaching Teeth |
| 8 Nov 2004 | K041392 | SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US | CAO Group, Inc. | EEG Heat Source for Bleaching Teeth |
| 13 Apr 1990 | K895174 | UNION BROACH BLEACHING LIGHT | Union Broach, Div. Moyco Industries, Inc. | EEG Heat Source for Bleaching Teeth |
| 14 Apr 1989 | K884937 | BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING | Grass-Telefactor Product Group | EEG Heat Source for Bleaching Teeth |
| 30 Oct 1986 | K862385 | SCHEIN BLEACHING UNIT | Henry Schein, Inc. | EEG Heat Source for Bleaching Teeth |
| 12 May 1986 | K854692 | MONARCH II BLEACHING INSTRUMENT | Almore Intl., Inc. | EEG Heat Source for Bleaching Teeth |
| 4 Oct 1983 | K832179 | HOT PROBE MODEL 6001 | Analytic Technology | EEG Heat Source for Bleaching Teeth |
| 10 Apr 1979 | K790378 | REYNOLDS BLEACHING PROCESS | Reynolds Laboratories | EEG Heat Source for Bleaching Teeth |