Manufacturer registered with FDA
GuangDong Roman Technology Co., Ltd
Dongguan, China. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 10
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What GuangDong Roman 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 | Vibrite Blue, TRI BEAM EDGE | 2024 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | ORAL IRRIGATION, MINI1 | 2018 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Brush Heads SN01, SN02, S121, S112, S170, S190, SK23, S070, S410, SC01, SC02, SC03, S560,S54, Pro Brush Head, Curve Brush Head, S62, Nova brush head, S59, S630Toothbrush sterilisation case: U8, UV Sterilizer, PX-UV1 | 2019 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | NX7000, NX8000, NX9000SL-T5, T36, Burst NovaT25, PX-001, SOC-SPT, ST038, BURSTkids Sonic ToothbrushT28, T35, Burst Pro, Burst CurveTOOTHBRUSH, POWERED, SonicYou, X20B | 2018 |
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 |
|---|---|---|
| GUANGDONG ROMAN TECHNOLOGY CO., LTDFDA reg. 3012803257 | Dongguan Guangdong, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10056757). 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.