Manufacturer registered with FDA
Pesitro Healthcare Products Co., Ltd.
Yangzhou, China. Lists 8 dental device types with FDA across 1 registered establishment.
- Device types listed
- 8
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 2389 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Pesitro Healthcare Products 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 | Pesitro Healthcare Products Co., Ltd. | 8 device types | — | Below |
| Colombia | INVIMA | Manufacturer | PESITRO HEALTHCARE PRODUCTS CO., LTD.PESITRO HEALTHCARE PRODUCTS CO.,LTD · PESITRO HEALTHCARE PRODUCTS CO, LTD | 389 | — | 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 Pesitro Healthcare Products 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 |
|---|---|---|---|---|
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | — | 2019 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | — | 2012 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | — | 2019 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | — | 2010 |
| Intraoral Dental WaxEGD · Class 1 | — | Maker | GRANULAR ORTHODONTICWAX(PRO);YANDY;90counts;Food-grade waxYANDY Orthodontic Gel Protection WaxYANDY Orthodontic Particle Protection Wax (Gel PRO) | 2010 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Maker | Flosser: Ultrahigh molecular weight polyethylene (UHMWPE) Handle: PPOrthodontic 2x Clean twin-line Floss Picks;YANDY;50 COUNTS | 2010 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | Interdental Pick | 2026 |
| Tongue ScraperLCN · Class 1 | — | Maker | Tongue ScraperFor Oral Care;YANDY;2PCS;Plastic parts PP;Rubber parts TPR | 2012 |
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 |
|---|---|---|
| PESITRO HEALTHCARE PRODUCTS CO., LTD.FDA reg. 3008262609 | Yangzhou Jiangsu, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10031762). 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.