Manufacturer registered with FDA
Chengdu Sani Medical Equipment CO.,LTD.
Chengdu, China. Lists 9 dental device types with FDA across 1 registered establishment.
- Device types listed
- 9
- Brands and models
- 14
- 510(k) clearances
- 0as applicant
- Markets registered in
- 8373 registrations outside the US
- Establishments
- 1China
Registered in 8 markets
Where regulators' registries name Chengdu Sani Medical Equipment 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 | Chengdu Sani Medical Equipment CO.,LTD. | 9 device types | — | Below |
| European Union | EUDAMED | Manufacturer | Chengdu Sani Medical Equipment Co.,Ltd. | 349 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | CHENGDU SANI MEDICAL EQUIPMENT CO., LTD. | 7 | 2024–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | CHENGDU SANI MEDICAL EQUIPMENT CO., LTD | 7 | 2019–2021 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Chengdu Sani Medical Equipment Co., Ltd | 5 | 2017–2018 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | CHENGDU SANI MEDICAL EQUIPMENT CO., LTD. | 2 | 2025–2025 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Chengdu Sani Medical Equipment Co., Ltd. | 2 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Chengdu Sani Medical Equipment Co Ltd | 1 | 2026–2026 | 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 Chengdu Sani Medical Equipment 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 |
|---|---|---|---|---|
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | Orthodontic Wires | 2024 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | Dental MirrorMicro Mirror | 2025 |
| Orthodontic Band DriverECT · Class 1 | Dental hand instruments | Maker | Electric Torque Driver | 2024 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | Composite instrumentsObturation System - Easy Fill; Obturation Downpack Device - Easy Pack; Condenser-N35/S70, N40/S80,N50/S100, N60/S120 | 2021 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | Palatal Expander | 2025 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | Blue Diamond BurCarbide Bur; Stainless Bur | 2018 |
| Gutta-PerchaEKM · Class 1 | Root canal filling materials | Maker | Gutta Percha Points, Model: Taper 02/03/04/06/F1-F5/Small/Primary/Large/XF-M, Gutta Percha Bar | 2021 |
| Endodontic Paper PointEKN · Class 1 | Root canal filling materials | Maker | Absorbent Paper Points, Model: Taper 02/03/04/06/F1-F5/Small/Primary/Large/XF-M | 2021 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | BS Rotary Endo Files, U File, Super C Root Canal Files, REAMERS Root Canal Files, K Files Root Canal Files,H Files Root Canal Files, TAPER FILE Rotary Endo Files, G3 Rotary Endo Files, Super Pass Rotary Endo Files,S3 Rotary Endo Files, KID Rotary Endo Files, S PRO Rotary Endo Files | 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 |
|---|---|---|
| CHENGDU SANI MEDICAL EQUIPMENT CO.,LTD.FDA reg. 3015060193 | Chengdu Sichuan, China | Contract manufacturer, Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10058743). 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.