Manufacturer registered with FDA
Plasdent Shanghai Co., Ltd.
Shanghai, China. Lists 17 dental device types with FDA across 1 registered establishment.
- Device types listed
- 17
- Brands and models
- 17
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What Plasdent Shanghai 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 | Absorber, Saliva, Paper, Paper Bibs, Paper Tray Covers | 2020 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Needle, Dental | 2020 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Mirror, Mouth | 2020 |
| Resin Impression Tray MaterialEBH · Class 1 | Impression trays | Maker | Material, Impression Tray, resin | 2020 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Unit, Syringe, Air and/or Water-syringe covers, tip covers | 2020 |
| Roll CottonEFN · Class 1 | — | Maker | cotton rolls | 2020 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Maker | Denture Cleanser | 2023 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | Toothbrush, Manual | 2020 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | Holder, Film, X-ray films | 2020 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | Evacuator, Evacuation Suction Tips, Oral Evacuation Tips | 2020 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | Syringe, periodontic, endodontic, irrigating | 2020 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Syringe, Restorative and Impression Material | 2020 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Retractors, Cheek Retractors | 2020 |
| Massaging PickJET · Class 1 | Floss & interdental cleaners | Maker | Picks, Soft Picks, Toothpicks, Plastic Wedges | 2020 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Absorber, Saliva, Paper, Paper Bibs, Paper Tray Covers | 2020 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Unit, operative dental, dental accessories | 2020 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Chair, Dental, without operative unit | 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 |
|---|---|---|
| PLASDENT SHANGHAI CO., LTD.FDA reg. 3017609565 | Shanghai, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10077952). 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.