Manufacturer registered with FDA
Sino Ortho Limited
HANGZHOU, ZHEJIANG, China. Lists 14 dental device types with FDA across 1 registered establishment.
- Device types listed
- 14
- Brands and models
- 14
- 510(k) clearances
- 0as applicant
- Markets registered in
- 37 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Sino Ortho 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 | Sino Ortho Limited | 14 device types | — | Below |
| Costa Rica | Ministerio de Salud | Manufacturer | SINO ORTHO LIMITED | 5 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | SINO ORTHO LIMITED | 2 | 2018–2018 | 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 Sino Ortho 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 |
|---|---|---|---|---|
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | lingual retainer, dental screw | 2006 |
| Orthodontic Material BandDYO · Class 1 | Orthodontic wires & bands | Maker | Molar band | 2006 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | preformed wire, orthodontic | 2006 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | buccal tube, molar tube | 2006 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | photographic mirror | 2024 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | orthodontic elastic, tie | 2006 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | COIL SPRINGS, DENTAL | 2008 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | bracket case | 2006 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | Cheek Retractor, Lip Retractor, Lateral Retractor, double side retractors, Lip depressors | 2017 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | braes, orthodontic | 2006 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | diamod burs | 2006 |
| Operative PliersEJY · Class 1 | Dental hand instruments | Maker | PLIERS, DENTAL | 2008 |
| Endodontic Pulp Canal FileEKS · Class 1 | Endodontic files | Maker | root canal | 2006 |
| Periodontic FileEMR · Class 1 | Dental hand instruments | Maker | protaper file | 2006 |
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 |
|---|---|---|
| SINO ORTHO LIMITEDFDA reg. 3005663302 | HANGZHOU Zhejiang, China | Contract manufacturer, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9085340). 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.