Manufacturer registered with FDA
Shanghai Dochem Industries Co., Ltd.
Shanghai, China. Lists 23 dental device types with FDA across 1 registered establishment.
- Device types listed
- 23
- Brands and models
- 57
- 510(k) clearances
- 0as applicant
- Markets registered in
- 10202 registrations outside the US
- Establishments
- 1China
Registered in 10 markets
Where regulators' registries name Shanghai Dochem Industries Co., Ltd. as the manufacturer or the registration holder of a device.
RegisteredHome: ChinaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Shanghai Dochem Industries Co., Ltd. | 23 device types | — | Below |
| Australia | TGA | Manufacturer | Shanghai Dochem Industries Co Ltd | 101 | 2007–2026 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Shanghai Dochem Industries Co.,Ltd. | 57 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SHANGHAI DOCHEM INDUSTRIES CO.,LTDSHANGHAI DOCHEM INDUSTRIES CO., LTD. | 24 | 2010–2026 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Shanghai Dochem Industries Co.,Ltd.Shanghai Dochem Industries Co. Ltd · Shanghai Dochem Industries Co., Ltd. · +2 | 11 | 2008–2023 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | SHANGHAI DOCHEM INDUSTRIES CO., LTDSHANGHAI DOCHEM INDUSTRIES CO.,LTD | 3 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | SHANGHAI DOCHEM INDUSTRIES CO., LTD.Shanghai Dochem Industries Co. ,Ltd. | 2 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SHANGHAI DOCHEM INDUSTRIES CO., LTD. | 2 | 2025–2025 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | SHANGHAI DOCHEM INDUSTRIES CO., LTD. | 1 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Shanghai Dochem Industries Co.,Ltd | 1 | — | 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 Dochem Industries 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 | evacuator tipsSaliva ejectorSurgical aspirator tipsTip Inserts/ Jet Inserts/ Surge Inserts | 2010 |
| Orthodontic Material BandDYO · Class 1 | Orthodontic wires & bands | Maker | Arch WiresLigature TiesPower Chains | 2022 |
| Dental NeedleDZM · Class 1 | Dental needles & syringes | Maker | Air/water Syringe tipCurved Utility SyringeDental headlightDental loupes/magnifierDisposable air/water syringe tipDisposable Pre-bent Needle tips | 2010 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Disposable Mouth Mirror | 2010 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | Elastic Placers | 2022 |
| Orthodontic Bracket AlignerECQ · Class 1 | Dental hand instruments | Maker | Orthodontic Brackets | 2022 |
| Roll CottonEFN · Class 1 | — | Maker | Cotton Roll | 2010 |
| X-Ray Film HolderEGZ · Class 1 | — | Maker | X-ray film holder, film-holder | 2010 |
| Abrasive DiskEHJ · Class 1 | Polishing & prophylaxis | Maker | Cosmetic Discs | 2023 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | Prophy BrushProphy Cup | 2023 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Disposable impression bite registration trayImpression trayTray Cover | 2010 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | Disposable dental impression syringe | 2010 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Cheek retractor | 2010 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | Single use dental probe; Spatula | 2010 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | baby tooth boxbarrier filmchair coverDenture BoxDisposable Intraoral Camera Sheathheadrest coverInfection Control Barrierplastic dappenplastic device sleevesplastic instrument sleeves 1 moreX-Ray Sensor Cover | 2010 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Dental bursDental PolisherDiamond BurTungsten Carbide Bur | 2010 |
| Operative Dental Amalgam CarverEKH · Class 1 | Dental hand instruments | Maker | amalgam carrierCuspidor StrainerDisposable traps( filter)Plastic retainer/ denture | 2010 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Gutta Percha Points | 2010 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | Niti/Stainless Steel Endo File | 2010 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | Single use dental tweezer | 2010 |
| Tube Impression and MatrixKCQ · Class 1 | — | Maker | Impression mixing tipsintra-oral tips | 2010 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Biodegradable Dental BibDental bib/apron | 2010 |
| Resin ApplicatorKXR · Class 1 | — | Maker | Bendable brush applicatorcomposite brush and replaceable tipMicro ApplicatorValustick Sticky Applicator | 2010 |
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 DOCHEM INDUSTRIES CO., LTD.FDA reg. 3008352964 | SHANGHAI, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10032110). 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.