Manufacturer registered with FDA
Shenzhen Fortunecome Technology Co.,Ltd.
Shenzhen, China. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 90
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What Shenzhen Fortunecome Technology Co.,Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Maker | — | 2015 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | FL-V16; FL-V17; FL-V18; FL-V19; FL-V20; FL-V22; FL-V23; FL-V24; FL-V26; FL-V27;FL-V28; FL-V29; FL-V30; FL-V31; FL-V32; FL-V33; FL-V35;FL-V36; FL-V41; FL-V42; FL-V43;FL-V5; FL-V5-X1; FL-V6; FL-V8; FL-V8-X1; FL-V8L; FL-V9;HL-B1; IP-1501; M008;JYQ831; JYQ832; JYQ833; JYQ834; JYQ835; JYQ836; JYQ837; JYQ838; JYQ839; JYQ840; JYQ841; JYQ842; JYQ843; JYQ844; JYQ845Model No.: FL-V2012;Model No.: FL-V2101, FL-V2102, FL-V2103, FL-V2104, FL-V2105, FL-V2106, FL-V2107, FL-V2108, FL-V2109, FL-V2110, FL-V2111;N008; ORAL IRRIGATOR; V18plus; V8plus; WF-03; X01; X02; X03;Oral Plaque & Tartar Remover Kit: FL-V34; FL-V38; FL-V39; FL-V40; C11; C22; C33; C44; C66; C77; C88; C99 2 moreUnit, Oral Irrigation - D008;YASI 911; YASI 912; YASI 913; YASI 915; YASI 916; YASI 917; | 2014 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | ELECTRONIC TOOTHBRUSHET01FL-A10FL-A100FL-A11FL-A12FL-A13FL-A14FL-A15FL-A150 68 moreFL-A16FL-A17FL-A18FL-A19FL-A20FL-A200FL-A21FL-A22FL-A22MFL-A23FL-A23MFL-A24FL-A24MFL-A25MFL-A26FL-A26MFL-A27FL-A27MFL-A28FL-A28MFL-A29FL-A29MFL-A30FL-A300FL-A30MFL-A350FL-A400FL-A450FL-A500FL-A550FL-A600FL-A8FL-A9FL-K01FL-K02FL-K03FL-K05FL-K06H002H003H007H008H009Model No.: FL-A2108, FL-A2109, FL-A2110, FL-A2111, FL- A2012ST01ST02ST03YASI 511YASI 517YASI 518YASI 702YASI 705YASI 708YS961YS962YS963YS964YS965YS967YS968YS969YS970YS971YS972YS973YS974YS975YS976 | 2014 |
| Sterile Ultraviolet Sanitation/Sterilization (for Toothbrushes) UnitMCF · Class 1 | — | Maker | — | 2015 |
| Ultraviolet Sanitation/Sterilization (for Toothbrushes) Unit Non-SterileNOB · Class 1 | — | Maker | — | 2015 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| Shenzhen Fortunecome Technology Co.,Ltd.FDA reg. 3011170521 | Shenzhen Guangdong, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10047995). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.