FDA Registration
Active
🇬🇧 United Kingdom
D B ORTHODONTICS LTD
Reg #: 3004730002
·
FEI: 3004730002
·
Expires 2026
Products
19
Proprietary Names
25
Establishment Types
6
Classifications
19
Registration Details
- Registration Name
- D B ORTHODONTICS LTD
- Registration Number
- 3004730002
- FEI Number
- 3004730002
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- RYEFIELD WAY, SILSDEN, KEIGHLEY
- City
- WEST YORKSHIRE England
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K100633
Owner / Operator
- Firm Name
- DB Orthodontics Limited
- Operator Number
- 9065879
- Address
- Unit 6, Ryefield Way, Silsden
- City
- Keighley
- State
- GB-NOTA
- Postal Code
- BD20 0EF
- Country
- GB
US Agent
- Business Name
- Rounding Third LLC dba Smile Stream Solutions
- Contact Name
- Tim Law
- Address
- Castle Rock, 1931 Liggett Rd Unit A16
- City
- Castle Rock
- State
- CO
- ZIP
- 80109
- Country
- US
- [email protected]
- Phone
- 888 2619933 ext. 100
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Attachment, Precision, All | EGG | Class 1 | Dental | No | 2017-04-28 |
| Point, Abrasive | EHL | Class 1 | Dental | No | 2016-12-15 |
| Plier, Orthodontic | JEX | Class 1 | Dental | No | 2015-07-21 |
| Mouthpiece, Saliva Ejector | DYN | Class 1 | Dental | No | 2016-12-15 |
| Band, Preformed, Orthodontic | ECM | Class 1 | Dental | No | 2016-12-15 |
| Retractor, All Types | EIG | Class 1 | Dental | No | 2016-12-15 |
| Implant, Endosseous, Orthodontic | OAT | Class 2 | Dental | No | 2014-06-17 |
| Instruments, Dental Hand | DZN | Class 1 | Dental | No | 2016-12-15 |
| Pliers, Operative | EJY | Class 1 | Dental | No | 2016-12-16 |
| Spring, Orthodontic | ECO | Class 1 | Dental | No | 2016-12-15 |
| Bracket, Metal, Orthodontic | EJF | Class 1 | Dental | No | 2016-12-15 |
| Mirror, Mouth | EAX | Class 1 | Dental | No | 2016-12-15 |
| Tube, Orthodontic | DZD | Class 1 | Dental | No | 2016-12-15 |
| Wire, Orthodontic | DZC | Class 1 | Dental | No | 2016-12-15 |
| Instrument, Ligature Tucking, Orthodontic | ECP | Class 1 | Dental | No | 2015-07-21 |
| Handle, Instrument, Dental | EJB | Class 1 | Dental | No | 2004-08-16 |
| Forceps, Dressing, Dental | EFL | Class 1 | Dental | No | 2015-07-21 |
| Band, Elastic, Orthodontic | ECI | Class 1 | Dental | No | 2016-12-15 |
| Bur, Dental | EJL | Class 1 | Dental | No | 2016-12-15 |
Proprietary Names
DB Orthodontics Bondable Buttons
Airo Interdental Strips
Nola Dry Field System
Evolve Molar Bands
DB Orthodontics Retractors
Infinitas Orthodontic Mini Implant Sterile
Ixion hand instruments
DB Orthodontics hand instruments
DB Orthodontic Instruments
DB Orthodontics Spring
DB Orthodontics Preformed Spring
DB Orthodontics Coil Spring
Evolve Orthodontic Brackets
DB Orthodontics Mirror
Evolve Flow Tube
Evolve Tube
Straight 8 Retainer Wire
DB Orthodontics Archwire
DB Orthodontics Wire Ligatures
DB Orthodontics Archwire (Reel)
Infinitas Orthodontic Mini Implant Non-Sterile
IXION
Colour Boutique Elastomeric Ligatures
Colour Boutique Chain
DB Orthodontic Rotary Dental Burs
Establishment Types
Foreign Private Label Distributor
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198
Export Device to the United States But Perform No Other Operation on Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device