Manufacturer registered with FDA
Changzhou Shengjie Medical Product Co., Ltd
Changzhou, China. Lists 3 dental device types with FDA across 1 registered establishment.
- Device types listed
- 3
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What Changzhou Shengjie Medical Product 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 |
|---|---|---|---|---|
| Saliva Ejector MouthpieceDYN · Class 1 | — | Maker | Saliva tips ,Evacuator tips, Surgical tips | 2024 |
| Roll CottonEFN · Class 1 | — | Maker | — | 2009 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Tray Cover | 2023 |
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 |
|---|---|---|
| Changzhou Shengjie Medical Product Co., LtdFDA reg. 3007774461 | Changzhou Jiangsu, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10029972). 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.