DB Orthodontics Limited
GB-MF-000023271 · United Kingdom · West Yorkshire
DB Orthodontics Limited is registered in the European database on medical devices as a manufacturer, with 461 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class IIa | 461 |
|---|
Most frequent device types declared: Colour Boutique Chain, Colour Boutique Ligatures, Colour Boutique Rotation Wedges, DB Instruments - Orthodontic Instruments, Diamond Burs.
Among these devices, 265 are declared reusable, 6 with a measuring function.
Authorised representative in the Union: Emergo Europe B.V..
Devices declared under this manufacturer
- Colour Boutique Closed Chain - Turquoise
- Colour Boutique Ligatures - Baby Pink
- Colour Boutique Mini Ligatures - Mixed Colours
- Colour Boutique Open Long Chain - Deep Pink
- Iconic Original 0.75mm 120mm Round Clear
- Interproximal Diamond Bur Fine
- Interproximal Diamond Bur Super Fine
- Ixion Distal End Long Handle
- Ixion Hard Wire Cutter With TC Inserts
- Ixion Light Wire Contouring & Cutting Plier
- Ixion Soft Ligature Cutter
- Photography Focus Double Ended V Retractor - Large
Showing 12 of 461 declared devices.
Catalogue references include DB03-3526, DB04-0178, DB04-0178L, DB04-1018, DB04-1019, DBL3-0602.
European nomenclature codes declared: Q010499, L150702, Q010404, Q010406, L150799, L150703.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | D B ORTHODONTICS LTD (GB) · FDA 3004730002 |
| Devices in EUDAMED | 461 |
| Country of registration | United Kingdom |
Device-level evidence
| Devices with a numeric GTIN | 461 |
|---|---|
| Found in the U.S. device database | 0 |
| Share | 0.0 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | DB ORTHODONTICS LTD |
North American profile: Both markets. DB Orthodontics Limited is registered in both the United States and Canada.
Notified body certificates
| Certificate | Status | Expiry |
|---|---|---|
MDR 835077 | supplemented | 2030-06-30 |