Manufacturer registered with FDA
Guangzhou OO Medical Scientific Limited
Guangzhou, China. Lists 15 dental device types with FDA across 1 registered establishment.
- Device types listed
- 15
- Brands and models
- 15
- 510(k) clearances
- 0as applicant
- Markets registered in
- 32 registrations outside the US
- Establishments
- 1China
Registered in 3 markets
Where regulators' registries name Guangzhou OO Medical Scientific 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 | Guangzhou OO Medical Scientific Limited | 15 device types | — | Below |
| Colombia | INVIMA | Manufacturer | GUANGZHOU OO MEDICAL SCIENTIFIC LIMITED | 1 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Guangzhou OO Medical Scientific Limited | 1 | 2025–2025 | 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 Guangzhou OO Medical Scientific 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 | Lister | OO Dental, Retainer, Screw Expansion | 2024 |
| Orthodontic Material BandDYO · Class 1 | Orthodontic wires & bands | Maker | OO Dental, Orthodontic seperators | 2023 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | OO Dental | 2017 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Maker | OO Dental, O-Tube | 2020 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Maker | OO Dental, Orthodontic ligature ties | 2023 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Maker | OO Dental, Orthodontic molar band | 2023 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Lister | OO Dental, Spring, Orthodontic | 2024 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | FORCEPS, DRESSING, DENTAL, OO Dental, OO MEDICAL, Orthodontic Forceps | 2025 |
| Oral Irrigation UnitEFS · Class 1 | Oral irrigators | Lister | OO Dental, Water Flosser | 2024 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Maker | OO Dental, OBRACE, O-EYES, Ceramic brackets | 2017 |
| Periodontic FileEMR · Class 1 | Dental hand instruments | Maker | OO Dental | 2017 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Lister | OO Dental, Orthodontic Tooth Brush, Electric Toothbrush | 2024 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Lister | FLOSS, DENTAL, OO Dental, OO MEDICAL, Toothpaste | 2025 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | OO Dental | 2021 |
| Indirect Bonding TrayQJJ · Class 1 | — | Maker | INDIRECT BONDING TRAY, OO Dental, OO MEDICAL, Orthodontic Indirect Bonding Tray, OBRACE GUIDE | 2025 |
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 |
|---|---|---|
| GUANGZHOU OO MEDICAL SCIENTIFIC LIMITEDFDA reg. 3013561919 | Guangzhou Guangdong, China | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10054513). 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.