Manufacturer registered with FDA
Hefei Xingcheng Sanitary Products CO.,LTD
Hefei, China. Lists 13 dental device types with FDA across 1 registered establishment.
- Device types listed
- 13
- Brands and models
- 28
- 510(k) clearances
- 0as applicant
- Markets registered in
- 233 registrations outside the US
- Establishments
- 1China
Registered in 2 markets
Where regulators' registries name Hefei Xingcheng Sanitary Products 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 | Hefei Xingcheng Sanitary Products CO.,LTD | 13 device types | — | Below |
| Colombia | INVIMA | Manufacturer | HEFEI XINGCHENG SANITARY PRODUCTS CO.LTDHEFEI XINGCHENG SANITARY PRODUCTS CO., LTD. · HEFEI XINGCHENG SANITARY PRODUCTS CO. LTD. · +2 | 33 | — | 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 Hefei Xingcheng Sanitary Products 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 ejectorSugical tip/ HV TIPSurgical tip | 2015 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Dental Mirror / Probe / Tweezer | 2026 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | Irrigation tip, Air water syringe tip | 2015 |
| Roll CottonEFN · Class 1 | — | Maker | Dental cotton roll , Dental cotton ball | 2015 |
| Prophylaxis CupEHK · Class 1 | Polishing & prophylaxis | Maker | Disposable Prophy Angle, Prophy cup, Prophy brush | 2015 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | Dental impression trayFluoride Trays Foam | 2016 |
| Irrigating Endodontic Periodontic SyringeEIC · Class 1 | Dental hand instruments | Maker | Dental needle | 2026 |
| Restorative and Impression Material SyringeEID · Class 1 | Dental hand instruments | Maker | Disposable Curved TipPre-bent applicator tips | 2016 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Dental Kit, Retainer Box | 2015 |
| Paper Saliva AbsorberKHR · Class 1 | — | Maker | Articulation paperDental bibTray cover Paper | 2015 |
| Resin ApplicatorKXR · Class 1 | — | Maker | Dental micro ApplicatorImpression Material GunMixing padMixing tipMixing wells | 2015 |
| Accessories Operative Dental UnitNRD · Class 1 | — | Maker | Barrier filmFull chair sleevesHalf chair sleevesSyringe sleevesTray cover sleevesX-ray barrier envelopes | 2015 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Headrest cover | 2026 |
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 |
|---|---|---|
| Hefei Xingcheng Sanitary Products CO.,LTDFDA reg. 3011707926 | Hefei Anhui, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10049340). 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.