Manufacturer registered with FDA
Shenzhen Rainbow Technology Co.,Ltd
Shenzhen, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 35 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Shenzhen Rainbow Technology Co.,Ltd as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Shenzhen Rainbow Technology Co.,Ltd | 2 device types | — | Below |
| Canada | Health Canada | Registration holder | SHENZHEN RAINBOW TECHNOLOGY CO., LTD. | 3 | 2026–2026 | Pure Global AI |
| Australia | TGA | Manufacturer | Shenzhen Rainbow Technology Co Ltd | 2 | 2026–2026 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Shenzhen Rainbow 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 |
|---|---|---|---|---|
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | Ultrasonic Teeth cleaner,ultrasonic dental cleaner,RB-016, RB-016B,RB-016C,RB-016D, RB-016F,RB-016G | 2023 |
| Mechanical Denture CleanerJER · Class 1 | Denture cleansers & adhesives | Maker | Ultrasonic Braces cleaner,retainer cleaner denture cleaner RB-038, RB-038B,RB-038C,RB-038D | 2024 |
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 RAINBOW TECHNOLOGY CO.,LTDFDA reg. 3018994966 | Shenzhen Guangdong, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10087485). 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.