Manufacturer registered with FDA
Shanghai smedent medical instrument co., ltd.
Shanghai, China. Lists 25 dental device types with FDA across 1 registered establishment.
- Device types listed
- 25
- Brands and models
- 25
- 510(k) clearances
- 0as applicant
- Markets registered in
- 46 registrations outside the US
- Establishments
- 1China
Registered in 4 markets
Where regulators' registries name Shanghai smedent medical instrument 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 | Shanghai smedent medical instrument co., ltd. | 25 device types | — | Below |
| Colombia | INVIMA | Manufacturer | SHANGHAI SMEDENT MEDICAL INSTRUMENT CO., LTD. | 2 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Shanghai Smedent Medical Instrument Co.,Ltd | 2 | 2026–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SHANGHAI SMEDENT MEDICAL INSTRUMENT CO., LTD. | 2 | 2016–2017 | 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 Shanghai smedent medical instrument 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 | — | Lister | Product: DYN - Mouthpiece, saliva ejector, saliva ejector tips, evacuator tips, aspirator tips | 2024 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Lister | Dappen dishes, spatulas, bite block, hand instrumentsdental wedges ,matrix band, bib clips, bite wing arm | 2024 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Lister | air water syringe tips plastic w/Metal core, metal air water syringe tips metal | 2024 |
| Articulation PaperEFH · Class 1 | — | Maker | Dental Articulating Paper | 2016 |
| Roll CottonEFN · Class 1 | — | Lister | cotton roll | 2024 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Lister | — | 2023 |
| X-Ray Film HolderEGZ · Class 1 | — | Lister | Plastic Film Holder, Bite Block, Barrier Envelope, Sensor Holder, Film Mount | 2025 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Lister | prophy angle ,prophy brush, prophy cup, prophy point | 2024 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | Impression tray performed, paper tray cover | 2024 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Lister | Curved Utility Syringe, Syringe, pre-bent needle tips ,Endodontic Irrigation Syringe | 2024 |
| Base Metal AlloyEJH · Class 2 | Dental alloys | Lister | Welding Wire, Welding Rod, Metal Powder, Alloy Powder , Co-Cr discs ,Titanium Discs | 2024 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Dental Diamond burs Dental Carbide burs | 2016 |
| Operative Dental Amalgam CarverEKH · Class 1 | Dental hand instruments | Lister | Disposable Traps, Plastic Retainer Denture, Cuspidor Strainer | 2025 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Lister | Starryshine | 2016 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Lister | Starryshine | 2016 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Lister | Starryshine | 2016 |
| Endodontic Pulp Canal ReamerEKP · Class 1 | Endodontic files | Lister | Starryshine | 2016 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Lister | Starryshine | 2016 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Lister | Starryshine | 2016 |
| Endodontic BroachEKW · Class 1 | Endodontic files | Lister | Starryshine | 2016 |
| Calculus Removal Hand InstrumentELA · Class 1 | Dental hand instruments | Lister | Polishing cup , polishing stone ,mounted stone, polishing point | 2024 |
| Paper Saliva AbsorberKHR · Class 1 | — | Lister | dental bibs, safe gauze ,non-woven gauze | 2024 |
| Resin ApplicatorKXR · Class 1 | — | Lister | applicator, resin - dental applicators, mixing pad; mixing well; brush handle, brush tips; | 2024 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Lister | air water syringe sleeve, plastic tray sleeve, full/half chair sleeve, headrest cover , barrier films | 2023 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Lister | paper tray cover | 2024 |
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 |
|---|---|---|
| SHANGHAI SMEDENT MEDICAL INSTRUMENT CO., LTDFDA reg. 3008370577 | Shanghai, China | Foreign exporter, Manufacturer, Private-label distributor, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10051351). 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.