Manufacturer registered with FDA
DB Orthodontics Limited
Keighley, United Kingdom. Lists 19 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.
- Device types listed
- 19
- Brands and models
- 25
- 510(k) clearances
- 22007–2010
- Markets registered in
- 48 registrations outside the US
- Establishments
- 1United Kingdom
510(k) clearances per year, 2000–2026
Registered in 4 markets
Where regulators' registries name DB Orthodontics 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 | DB Orthodontics Limited | 2 clearances | 2007–2010 | Below |
| Taiwan | TFDA | Manufacturer | DB ORTHODONTICS LTDDB ORTHODONTICS LTD. | 4 | 2006–2023 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | DB ORTHODONTICS | 2 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | DB Orthodontics LimitedDB Orthodontics Ltd. | 2 | — | 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 DB Orthodontics 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 Endosseous ImplantOAT · Class 2 | — | Maker | Infinitas Orthodontic Mini Implant Non-SterileInfinitas Orthodontic Mini Implant Sterile | 2007 |
| Saliva Ejector MouthpieceDYN · Class 1 | — | Lister | Nola Dry Field System | 2016 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Lister | DB Orthodontics ArchwireDB Orthodontics Archwire (Reel)DB Orthodontics Wire LigaturesStraight 8 Retainer Wire | 2016 |
| Orthodontic TubeDZD · Class 1 | Orthodontic wires & bands | Lister | Evolve Flow TubeEvolve Tube | 2016 |
| Dental Hand InstrumentsDZN · Class 1 | Dental hand instruments | Maker | DB Orthodontics hand instrumentsIxion hand instruments | 2016 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Lister | DB Orthodontics Mirror | 2016 |
| Orthodontic Elastic BandECI · Class 1 | Orthodontic wires & bands | Lister | Colour Boutique ChainColour Boutique Elastomeric Ligatures | 2016 |
| Orthodontic Preformed BandECM · Class 1 | Orthodontic wires & bands | Lister | Evolve Molar Bands | 2016 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Lister | DB Orthodontics Coil SpringDB Orthodontics Preformed SpringDB Orthodontics Spring | 2016 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Maker | — | 2015 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | — | 2015 |
| All Precision AttachmentEGG · Class 1 | — | Lister | DB Orthodontics Bondable Buttons | 2017 |
| Abrasive PointEHL · Class 1 | Polishing & prophylaxis | Lister | Airo Interdental Strips | 2016 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Lister | DB Orthodontics Retractors | 2016 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | IXION | 2004 |
| Orthodontic Metal BracketEJF · Class 1 | Orthodontic brackets | Lister | Evolve Orthodontic Brackets | 2016 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Lister | DB Orthodontic Rotary Dental Burs | 2016 |
| Operative PliersEJY · Class 1 | Dental hand instruments | Lister | DB Orthodontic Instruments | 2016 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | — | 2015 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names DB Orthodontics Limited as the applicant.
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| D B ORTHODONTICS LTDFDA reg. 3004730002 | WEST YORKSHIRE England, United Kingdom | Complaint file establishment, Foreign exporter, Manufacturer, Private-label distributor, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9065879). 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.