Miscellaneous devices · 21 CFR 872 Subpart G
Dental Stain Eraser
FDA device type “Eraser, Dental Stain”.
- Companies listing it
- 6647 makers
- Brands and models
- 242
- 510(k) clearances
- 20 in five years
- FDA name
- Eraser, Dental Stain
510(k) clearances per year, 1976–2026
Companies that list MAU
66 companies currently list this device type with FDA.
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Sdi Limited | Australia | Maker | Pola Fresh | 8 | 2022 |
| Pac-Dent Inc. | United States | Maker | iBrite Teeth Whitening Gel | 5 | 2022 |
| Keystone Industries | United States | Maker | NIU Bleaching Systems | 2 | 2025 |
| DMG Chemisch-Pharmazeutische Fabrik GmbH | Germany | Maker | Flairesse Bleaching Gel CP 10% Refill · Flairesse Bleaching Gel CP 10% Starter Kit · Flairesse Bleaching Gel CP 16% Refill · Flairesse Bleaching Gel CP 16% Starter Kit · +2 | 4 | 2022 |
| Vigodent Industria e Comercio Ltda | Brazil | Maker | Pasta Herjos F | 1 | 2025 |
| Nanova Biomaterials Inc | United States | Maker | Novashine Teeth Whitening Gel Refill Pack · NovaShine Teeth Whitening Pen · NovaShine Whitening Kit | 5 | 2018 |
| Manufacturera Dental Continental | Mexico | Maker | AntiVet Whitening Kit | 2 | 2001 |
| Temrex Corp. | United States | Maker | GEL-WHITE / STAR WHITE | 2 | 2012 |
| Zhengzhou Huaer Electro-optics Technology Co., Ltd. | China | Maker | BlanQuest Home Whitening Kit GB-HOM101 · BlanQuest Pro Professional Whitening Treatment Kit GB-PRO101 · Charcoal Teeth Whitening Powder, Charcoal teeth whitening strips, charcoal foam toothpaste, · Coconut oil teeth whitening pulling, bamboo toothbrushes, teeth whitening strips, desentitization gel, · +14 | 1 | 2020 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | China | Maker | Dione Cold Light Tooth Whitening Instrument, Enamel Care/Colour Corrector/Hyaluronic Serum · Teeth Whitening Kit(Regular Strength Serum,Maximum Strength Serum,Desensitizing Serum,Teeth Whitening GEL · Teeth Whitening Pen, Teeth Whitening Toothpaste, teeth whitening machine, Whitening Materials | — | — |
| Jiangxi IVISMILE Technology Co.,Ltd | China | Maker | Aroamas Teeth Whitening Pen 3 Pack; Aroamas TEETH WHITENING KIT; AsaVea Teeth Whitening Pen (2 Pack); · AsaVea Premium Teeth Whitening Kit, LED Light; Dry Strips; Dissolving Strip; Teeth Whitening Pen; Bleaching Pen; · BANANA WHITE Teeth Whitening Gel; BANANA WHITE Teeth Whitening Kit; Coconut Oil Sachet; · Be Lucent Glow teeth whitening strips; White&Go Purple Teeth Whitening Strip; Smile Genius Purple Teeth Whitening Strip; · +22 | — | — |
| Guangzhou Xinuo Technology Co., Ltd | China | Maker | Dissolving Strip: Teeth Whitening Powder; Charcoal Teeth Whitening Powder; Double Barrel Syringe Gel · Double Elastic Gel Strips/Dry Strips/Teeth Bleaching System/Teeth Bleaching Kit /teeth whitening foam; · Dual Barrel Gel, Double Barrel Gel, Dual Barrel Syringe Gel · Natural+ LED teeth whitening lamp;ProLite Teeth Whitening Device · +5 | — | — |
| Shenzhen Senlede Technologies Co., Ltd | China | Maker | Dissolving Strip: Teeth Whitening Powder; Charcoal Teeth Whitening Powder; Double Barrel Syringe Gel; · ProLite Teeth Whitening Device; Natural+ LED teeth whitening lamp; · Teeth Bleaching Kit /teeth whitening foam; Teeth Whitening Mouth Tray Led Light · Teeth Whitener Teeth Whitening Gel 3ml /5ml/10ml; Professional Whitening Gel: Remineralization Gel/ Desensitizing Gel · +4 | — | — |
| Jiangxi Dentalbright Technology Co., Ltd | China | Maker | BE LUCENT NHpro Enamel Care; BE LUCENT HA5 Gum Serum · charcoal teeth whitening powder,coconut oil pulling;coconut oil sachet, BE LUCENT Teeth Whitening Pen · Dissolving Strips · Dual Barrel Gel, Double Barrel Gel, Dual Barrel Syring Gel, Double Barrel Syringe Gel · +13 | — | — |
| Nanchang White Technology Co., Ltd. | China | Maker | Charcoal Teeth Whitening Powder,Coconut Oil Pulling;Coconut Oil Sachet, BE LUCENT Teeth Whitening Pen; · Charcoal Teeth Whitening Strips; V34 Colour Corrector; V34 Colour Corrector Foam; NHpro Enamel Care; · Dissolving Strips; Dual Barrel Gel, Double Barrel Gel, Dual Barrel Syring Gel, Double Barrel Syringe Gel; · HA5 Hyaluronic Serum; Xquisite Smile Teeth Whitening Kit · +5 | — | — |
| Ningbo Cooskin Stationery Co., Ltd. | China | Maker | Dione Cold Light Tooth Whitening Instrument, Teeth Whitening GEL, Whitening Materials | — | — |
| Beaming White LLC | United States | Maker | Advanced kit · Beaming White Take-home kit · Forever White Headset kit · Forever White pen · +2 | — | — |
| Onuge Personal Care(Guangdong)Manufacturer Group Co., LTD. | China | Maker | BocaBella Natural Teeth Whitening Strips · BocaBella Teeth Whitening U-wraps · Charcoal Teeth Whitening Powder · Dentiguard LED Teeth Whitening Kit · +10 | — | — |
| Ekong Technology Co., Limited. | China | Maker | Double Barrel Syringe Gel; 3ml/5ml/10ml/PROFESSIONAL WHITENING GEL, · Dry Strips; Dissolving Strip; Teeth Whitening Pen; Bleaching Pen, Teeth Whitener; Teeth Whitening Gel · Portable Teeth Whitening kit; Teeth Whitening Strips System; Teeth Bleaching Kit, Teeth Whitening Strips · Professional Whitening Gel, Dual Barrel Gel; Double Barrel Gel; Dual Barrel Syringe Gel · +5 | — | — |
| LLRN Personal Care (Shenzhen) Co.,ltd | China | Maker | Charcoal Teeth Whitening Powder, Charcoal, Teeth Whitening Strips,V34 Colour Corrector, V34 Colour Corrector Foam, · Desensitizing Gel, Teeth Whitening Kit, Teeth Whitening Home Kit, Teeth Whitening System, Teeth Bleaching System, · Dry Teeth Whitening Strips, Dissolving Strip, Teeth Whitening Pen, Bleaching Pen, Teeth Whitener, · Dual Barrel Gel, Double Barrel Gel, Dual Barrel Syring Gel, Double Barrel Syringe Gel, Remineralization Gel, · +3 | — | — |
| New Phenix Home Products Manufactory Co Ltd | China | Maker | DENTAL STAIN ERASER · Dr. Smith · Oral-Care | — | — |
| Viarden Lab LLC | United States | Maker | INSTABRIGHT VIARDEN LAB | — | — |
| Jiangxi Ushine Bright Medical Co., Ltd. | China | Maker | BE LUCENT NHpro Enamel Care; BE LUCENT HA5 Gum Serum · Charcoal Teeth Whitening Powder/ Teeth Whitening Powder/ Coconut Oil Pulling/ Coconut Oil Sachet/ Dual Barrel Gel/ · Charcoal Teeth Whitening Strips/ V34 Teeth Whitening Strips/ Teeth Whitening Essence/ Teeth Whitening Foam/ · Double Barrel Gel/ Double Barrel Syringe Gel/ Teeth Remineralization Gel/ Teeth Desensitizing Gel/ Teeth Whitening Kit/ · +4 | — | — |
| Shenzhen Golden Wish Personal Care Co.,Ltd | China | Maker | charcoal powder; charcoal teeth whitening powder; Charcoal Teeth Whitening Strips; charcoal toothpaste · coconut oil pulling; coconut oil sachet; Dissolving Strips; Dual Barrel Gel; Fruit Toothpaste · PearlSmile Teeth Whitening Kit; Purple Toothpaste · Remineralization Gel/Desensitizing Gel/Teeth Whitening Kit/Teeth Whitening Home Kit · +4 | — | — |
| Changzhou IVORIE Shengmei Packaging Technology Co.Ltd | China | Maker | Coconut oil pulling; Coconut oil sachet, Oral care kit, Toothpaste · Double Elastic Gel Strips/Dry Strips/Dissolving Strip; teeth whitening powder; charcoal teeth whitening powder · PROFESSIONAL WHITENING GEL; Remineralization Gel/Desensitizing Gel/Teeth Whitening Kit/Teeth Whitening Home Kit · Teeth Bleaching System/Teeth Bleaching Kit/Teeth Whitening Strips · +2 | — | — |
| Hager & Werken | Germany | Maker | MIRAWHITE PRO | — | — |
| Fuzhou Delphin Bio-tech Co., Ltd. | China | Maker | DSI Prophy Laxis Teeth Whitening Powder, DSI Teeth Whitening Strips, DSI Toothpaste · PurelyWHITE DELUXE Teeth Whitening Kit, PurelyWHITE Whitening Kit refill, MEANSMILE Teeth Whitening Kit · Teeth color corrector gel, teeth whitening pen, teeth whitening kit, teeth whitening foam, teeth whitening liquid, · Teeth Remineralizing Gel, Teeth Desensitizing Gel, DSI Prophy Laxis Paste · +1 | — | — |
| Shandong Zhushi Pharmaceutical Group Co., Ltd | China | Maker | Dione Cold Light Tooth WhiteningInstrument, Enamel Care/Colour Corrector/Hyaluronic Serum · Teeth Whitening Kit(Regular Strength Serum,Maximum Strength Serum,Desensitizing Serum,Teeth Whitening GEL> , · Teeth Whitening Pen, Teeth Whitening Toothpaste, teeth whitening machine, Whitening Materials, | — | — |
| Heyuan Hey White Technology Co., Ltd. | China | Maker | Dentifrice kits, teeth whitening pen · Purple color corrector whitening gel · Teeth Whitening Kit, Teeth Whitening Gel, Charcoal Teeth Whitening Powder, · Teeth Whitening Strips; Ionic teeth whitening device | — | — |
| Huizhou Gold Rose Technology Co.,Ltd | China | Maker | Teeth Whitening Kit | — | — |
| Shenzhen Balinda Technology Co.,Ltd | China | Maker | Teeth Whitening Kit/Teeth Whitening Pen/Teeth Whitening Gel//Teeth Whitening Strips · Teeth Whitening Powder/Teeth whitening foam | — | — |
| Shenzhen Baotonghui Industrial Co.,Ltd | China | Maker | Teeth whitening products | — | — |
| Yangzhou Royal Home Products Manufacture Co., Ltd. | China | Maker | Eraser, Dental Stain | — | — |
| Indusbello Ind. e Com. de Prod. Med. e Odont. Ltda. | Brazil | Maker | INDUSBELLO | — | — |
| Foshan Ousidun Personal Care Products Co.,Ltd | China | Maker | Teeth whitening Gel · Teeth Whitening Pen · Teeth Whitening Strips | — | — |
| Tree of Life Pharma Ltd. | Israel | Maker | BRIGHT WHITE · CLEVER WHITE · IBRIGHT TEETH WHITENING GEL · PERFECT SMILE · +2 | — | — |
| VH Technologies Ltd | United States | Maker | DiaShine · Lucida | — | — |
| Changzhou Freshday Household Products Corp. Ltd. | China | Maker | Charcoal Teeth Whitening Powder, Coconut Oil Pulling, Coconut Oil Sachet, Desentisizing Gel/Teeth Whitening Kit, · Dental Tongue Cleaner | — | — |
| NINGBO Chibanda IMP &EXP CO, LTD | China | Maker | teeth whitening pen | — | — |
| Yangzhou E. S. Toothbrush Co., Ltd. | China | Maker | TOOTH POWDER; teeth whitening strips | — | — |
| Guang Xi FuLaiMing Biopharmaceutics Co., Ltd. | China | Maker | (Desensitizing Toothpaste):15g/ piece, 20g/ piece, 30g/ piece, 60g/ piece, 80g/ piece, 90g/ piece, · 100g/ piece, 110g/ piece, 120g/ piece, 130g/ piece, 140g/ piece | — | — |
| Movemints, LLC | United States | Maker | Movemints Aligner and Retainer Cleaner plus Whitening | — | — |
| Baxter Laboratories | Australia | Maker | Pola Fresh Advanced Tooth Whitening and Cleansing Foam | — | — |
| Eastern Progress Plastic & Electronic Manufactory Co., Ltd. | China | Maker | — | — | — |
| Zhengzhou Boma Biotech Co.,Ltd | China | Maker | Teeth Whitening Strips, Teeth Whitening Pen, Teeth Whitening Powder, Teeth Whitening Foam, Toothpaste | — | — |
| LED Technologies, Inc. | United States | Maker | — | — | — |
| Samson Innovation Corp. Ltd. | Hong Kong SAR China | Maker | — | — | — |
| Park Dental Research Corp | United States | Contract manufacturer | Remineralization Gel/Desensitizing Gel/Teeth Whitening Kit/Teeth Whitening Home Kit/Teeth Whitening System | 8 | 2026 |
| Cosmedent, Inc. | United States | Repacker / relabeler | Cosmedent Easywhite | 27 | 2024 |
| Vitang Technology LLC | United States | Manufacturer | Teeth Whitening Pen | 1 | 2020 |
| Dentimed Sao Joao LLC | United States | Repacker / relabeler | STAR5 | — | — |
| TitanLinks Logistics LLC | United States | Repacker / relabeler | Dental Cement | — | — |
| Ortho Pro Dent LLC | United States | Repacker / relabeler | devonwhite bleaching , in office bleaching , devonwhite smile , Pro white smile, Pro white bleaching , dental bleaching · devonwhite in office bleaching system | — | — |
| Soher Med Limited | Hong Kong SAR China | Foreign exporter | Dental Cement | — | — |
| Ortho Dental Lab, LLC | United States | Manufacturer | SmileSet Premium Sensitive Whitening Strips · SmileSet Premium Whitening · SmileSet Premium Whitening Kit · SmileSet Premium Whitening Pen · +1 | — | — |
| WSD Labs Usa Inc. | United States | Repacker / relabeler | Coconut oil pulling; Coconut oil sachet · Dry Strips/Dissolving Strip; teeth whitening powder; charcoal teeth whitening powder · Dual Barrel Gel, Double Barrel Gel, Dual Barrel Syring Gel, Double Barrel Syringe Gel; · Remineralization Gel/Desensitizing Gel/Teeth Whitening Kit/Teeth Whitening Home Kit/Teeth Whitening System; · +2 | — | — |
| Cordica Medical (Formally Team Technologies, Inc) | United States | Contract manufacturer | — | — | — |
| Shenzhen Mold and Manufacturing Co Ltd | China | Contract manufacturer | Beaming White | — | — |
| Double White Medical Technology Development(Guangzhou) Co. L | China | Foreign exporter | Charcoal Teeth Whitening Powder; CVS HEALTH TEETH WHITENING PEN; Dentiguard LED Teeth Whitening Kit; · EEG Teeth Whitening Kit; Enlight Trading Inc.; Teeth Whitening Gel · Teeth Whitening Dry Strips, Teeth Whitening Gel Strips, Teeth Whitening U-wraps,Teeth Whitening Strips · Teeth Whitening Gel 2ml/ 3ml/ 5ml /10ml; Teeth Whitening Home Kit · +2 | — | — |
| Guangzhou White Pro Oral Care Products Co., Ltd. | China | Foreign exporter | Charcoal Teeth Whitening Powder; CVS HEALTH TEETH WHITENING PEN · Dentiguard LED Teeth Whitening Kit;; EEG Teeth Whitening Kit; Enlight Trading Inc · Teeth Whitening Gel; Teeth Whitening Dry Strips, Teeth Whitening Gel Strips · Teeth Whitening Home Kit; Teeth Whitening Kit; Teeth Whitening Pen · +2 | — | — |
| Gurunanda LLC | United States | Contract manufacturer | MENTADENT WHITENING | — | — |
| Hefei Haixi Trading Co., Ltd. | China | Repacker / relabeler | Mini Toothpaste | — | — |
| Buy Asia Enterprise Ltd | China | Foreign exporter | Tooth Stain Eraser | — | — |
| Gravitiq LLC | United States | Lister | — | — | — |
| Oketz Logistics LLC | United States | Repacker / relabeler | — | — | — |
| Swedent Dental Wholesale Group | United States | Repacker / relabeler | — | — | — |
510(k) clearances
| Decided | 510(k) | Device | Applicant |
|---|---|---|---|
| 3 May 2000 | K000140 | CLINI-DENT | The Precident Group |
| 14 Nov 1989 | K891338 | SMYLON (DENTAL STAIN ERASER) | The Smylon Co. |
Official records: FDA product classification for MAU · 21 CFR 872.6855.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026