Data / Medical devices / United Kingdom / D B Orthodontics Ltd
D B Orthodontics Ltd: FDA-registered device maker in WEST YORKSHIRE England, United Kingdom, 2 510(k) clearances
D B Orthodontics Ltd is registered with the FDA (registration 3004730002) in WEST YORKSHIRE England, United Kingdom. It lists 19 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 1, 2010. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004730002
- Address
- Ryefield Way Silsden, Keighley, WEST YORKSHIRE England, United Kingdom, BD20 0EF
- Owner or operator
- DB Orthodontics Limited (9065879)
- Roles
- Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- August 16, 2004
- Registered through
- 2026
- Brand names listed
- Airo Interdental Strips, Colour Boutique Chain, Colour Boutique Elastomeric Ligatures, DB Orthodontic Instruments, DB Orthodontic Rotary Dental Burs, DB Orthodontics Archwire, DB Orthodontics Archwire (Reel), DB Orthodontics Bondable Buttons and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Attachment, Precision, All | EGG | 1 | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Band, Elastic, Orthodontic | ECI | 1 | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Band, Preformed, Orthodontic | ECM | 1 | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Bracket, Metal, Orthodontic | EJF | 1 | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Bur, Dental | EJL | 1 | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Forceps, Dressing, Dental | EFL | 1 | Complaint file establishment, Foreign private label distributor, Manufacturer, Specification developer | accessdata.fda.gov |
| Handle, Instrument, Dental | EJB | 1 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Orthodontic | OAT | 2 | Complaint file establishment, Foreign private label distributor, Specification developer | accessdata.fda.gov |
| Instrument, Ligature Tucking, Orthodontic | ECP | 1 | Complaint file establishment, Foreign private label distributor, Manufacturer, Specification developer | accessdata.fda.gov |
| Instruments, Dental Hand | DZN | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Mouthpiece, Saliva Ejector | DYN | 1 | Exporter to the US | accessdata.fda.gov |
| Plier, Orthodontic | JEX | 1 | Complaint file establishment, Foreign private label distributor, Manufacturer, Specification developer | accessdata.fda.gov |
| Pliers, Operative | EJY | 1 | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Point, Abrasive | EHL | 1 | Exporter to the US | accessdata.fda.gov |
| Retractor, All Types | EIG | 1 | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Spring, Orthodontic | ECO | 1 | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Tube, Orthodontic | DZD | 1 | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
| Wire, Orthodontic | DZC | 1 | Complaint file establishment, Foreign private label distributor, Repackager or relabeler | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 1, 2010 | K100633 | INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016 | OAT | Substantially Equivalent | D B Orthodontics, Ltd. | accessdata.fda.gov |
| October 26, 2007 | K072086 | INFINITAS MINI-IMPLANT SYSTEM/GUIDANCE SYSTEM | OAT | Substantially Equivalent | D B Orthodontics, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Pliers, Operative
- All makers of Forceps, Dressing, Dental
- All makers of Implant, Endosseous, Orthodontic
- All makers of Spring, Orthodontic
- All makers of Instruments, Dental Hand
- All makers of Attachment, Precision, All
Updated April 1, 2010. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.