Manufacturer registered with FDA
BGSS Company Asia Limited
Zhabei, China. Lists 14 dental device types with FDA across 1 registered establishment.
- Device types listed
- 14
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1China
Devices listed with FDA
What BGSS Company Asia Limited 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 | — | 2011 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | — | 2011 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | — | 2011 |
| Roll CottonEFN · Class 1 | — | Maker | — | 2011 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Maker | — | 2011 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | TRAY COVER | 2018 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | — | 2011 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | — | 2011 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | — | 2011 |
| Endodontic Pulp Canal ReamerEKP · Class 1 | Endodontic files | Maker | — | 2011 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | — | 2011 |
| Disposable Fluoride TrayKMT · Class 1 | — | Maker | — | 2011 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | — | 2011 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | BARRIER SLEEVES | 2018 |
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 |
|---|---|---|
| BGSS COMPANY ASIA LIMITEDFDA reg. 3009219448 | Zhabei Shanghai, China | Contract manufacturer, Foreign exporter, Manufacturer, Private-label distributor, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10038365). 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.