Manufacturer registered with FDA
Hi-P (Xiamen) Precision Plastic Manufacturing Co.,
XIAMEN, China. Lists 5 dental device types with FDA across 1 registered establishment.
- Device types listed
- 5
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 24 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Hi-P (Xiamen) Precision Plastic Manufacturing Co., 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 | Hi-P (Xiamen) Precision Plastic Manufacturing Co., | 5 device types | — | Below |
| Colombia | INVIMA | Manufacturer | HIP (XIAMEN) PRECISION PLASTIC MANUFACTURING CO., LTDHI-P (XIAMEN) PRECISION PLASTIC MANUFACTURING CO. LTD · HI-P (XIAMEN) PRECISION PLASTIC MANUFACTURING CO., LTD | 4 | — | 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 Hi-P (Xiamen) Precision Plastic Manufacturing Co., 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 | COLGATE OPTIC WHITE PROFESSIONAL | 2018 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Maker | quip Rechargeable Water Flosser | 2022 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | COLGATE MANUAL TOOTHBRUSH | 2018 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Maker | COLGATE POWERED TOOTHBRUSH | 2006 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | — | 2020 |
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 |
|---|---|---|
| HI-P (XIAMEN) PRECISION PLASTIC MANUFACTURING CO.,FDA reg. 3005607635 | XIAMEN Fujian, China | Contract manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9083459). 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.