Miscellaneous devices · 21 CFR 872 Subpart G
Heat Source for Bleaching Teeth
FDA device type “Heat Source For Bleaching Teeth”.
- Companies listing it
- 11182 makers
- Brands and models
- 218
- 510(k) clearances
- 120 in five years
- FDA name
- Heat Source For Bleaching Teeth
510(k) clearances per year, 1976–2026
Companies that list EEG
111 companies currently list this device type with FDA.
| 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 | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 27 Nov 2012 | K122725 | TANDA PEARL, ULTRAWYTE, PEARL | Syneron Beauty |
| 12 Jan 2012 | K110888 | ABSOLUTE WHITE LIGHT | Dr. Fresh, Inc. |
| 20 Feb 2007 | K063704 | BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101 | Beks Incorporated |
| 18 Oct 2005 | K052040 | QUICKSMILE | Cosmetic Dental Materials, Inc. |
| 8 Nov 2004 | K042153 | SOUTH BEACH SMILE LIGHT WHITENING SYSTEM | Dentovations, Inc. |
| 8 Nov 2004 | K041392 | SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US | CAO Group, Inc. |
| 13 Apr 1990 | K895174 | UNION BROACH BLEACHING LIGHT | Union Broach, Div. Moyco Industries, Inc. |
| 14 Apr 1989 | K884937 | BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING | Grass-Telefactor Product Group |
| 30 Oct 1986 | K862385 | SCHEIN BLEACHING UNIT | Henry Schein, Inc. |
| 12 May 1986 | K854692 | MONARCH II BLEACHING INSTRUMENT | Almore Intl., Inc. |
| 4 Oct 1983 | K832179 | HOT PROBE MODEL 6001 | Analytic Technology |
| 10 Apr 1979 | K790378 | REYNOLDS BLEACHING PROCESS | Reynolds Laboratories |
Official records: FDA product classification for EEG · 21 CFR 872.6475.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026