Manufacturer registered with FDA
Sinol Dental Limited
XIANYANG, China. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 5
- 510(k) clearances
- 0as applicant
- Markets registered in
- 32 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Sinol Dental Limited 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 | Sinol Dental Limited | 4 device types | — | Below |
| Australia | TGA | Manufacturer | Sinol Dental Limited | 1 | 2025–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | SINOL DENTAL LIMITED | 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 Sinol Dental 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 |
|---|---|---|---|---|
| Operative Dental UnitEIA · Class 1 | Dental chairs & operative units | Maker | Dental Unit with Chair | 2008 |
| Dental Operating LightEAZ · Class 1 | Dental operating lights | Maker | Dental Light | 2012 |
| Dental Air-Powered HandpieceEFB · Class 1 | Dental handpieces | Maker | Dental Low Spped Handpiece includinHigh Speed Air Turbine Handpiece Se | 2010 |
| Dental Chair without Operative UnitNRU · Class 1 | Dental chairs & operative units | Maker | Dental Chair | 2008 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Sinol Dental Limited lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: North West Medical Instrument (Group) Co., Ltd. (2), Xianyang North West Medical Instrument (Group) Co. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 26 Jul 2013 | K130410 | DENTAL UNIT WITH CHAIR | Xianyang North West Medical Instrument (Group) Co. | EIA Operative Dental Unit |
| 22 Apr 2010 | K093971 | DENTAL HANDPIECE | North West Medical Instrument (Group) Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 4 Apr 2008 | K080438 | DENTAL UNIT WITH CHAIR | North West Medical Instrument (Group) Co., Ltd. | EIA Operative Dental Unit |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SINOL DENTAL LIMITEDFDA reg. 3007031016 | Xianyang Shaanxi, China | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10025657). 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.