Manufacturer registered with FDA
Taizhou Polus Technology Co., Ltd.
Taizhou, China. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 10
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Taizhou Polus 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 | Taizhou Polus Technology Co., Ltd. | 2 device types | — | Below |
| Israel | AMAR | Manufacturer | Taizhou Polus Technology Co.,Ltd. | 1 | — | 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 Taizhou Polus 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 | 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)Gemini® Teeth Whitening Accelerator Home Edition (BY-GM224) | 2003 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | BEYOND FlexiPro Cheek Retractor (5 pack) (BY-M015)BEYOND FlexiPro Cheek Retractor (Single pack) (BY-M016)BEYOND® FlexiBlue® Comfort Cheek Retractor (5 pack L Size) (BY-PD01205L)BEYOND® FlexiBlue® Comfort Cheek Retractor (5 pack M Size) (BY-PD01205M)BEYOND® II Cheek Retractor (5 pack) (BY-M012) | 2007 |
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 |
|---|---|---|
| Taizhou Polus Technology Co., Ltd.FDA reg. 3004105228 | Taizhou Zhejiang, China | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9057652). 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.