FDA Registration
Active
🇬🇧 United Kingdom
WRIGHT HEALTH GROUP
Reg #: 3003103749
·
FEI: 3003103749
·
Expires 2026
Products
6
Proprietary Names
8
Establishment Types
3
Classifications
6
Registration Details
- Registration Name
- WRIGHT HEALTH GROUP
- Registration Number
- 3003103749
- FEI Number
- 3003103749
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Dunsinane Avenue, Kingsway West
- City
- Dundee Dundee City
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K122955
Owner / Operator
- Firm Name
- Wright Health Group
- Operator Number
- 10036258
- Address
- Dunsinane Avenue, Kingsway West
- City
- Dundee
- State
- Dundee City
- Postal Code
- DD2 3QD
- Country
- GB
- Correspondent
- Ian L Matheson
US Agent
- Business Name
- RAF SOLUTIONS USA, INC
- Contact Name
- Edwin Lindsay
- Address
- 10124 N.W. 53rd Street, Sunrise
- City
- Fort Lauderdale
- State
- FL
- ZIP
- 33351
- Country
- US
- [email protected]
- Phone
- 305 9607262
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Denture, Plastic, Teeth | ELM | Class 2 | Dental | No | 2013-03-12 |
| Wax, Dental, Intraoral | EGD | Class 1 | Dental | No | 2021-07-26 |
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2016-09-23 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2011-04-26 |
| Material, Impression | ELW | Class 2 | Dental | No | 2017-06-08 |
| Alloy, Other Noble Metal | EJS | Class 2 | Dental | No | 2015-01-14 |
Proprietary Names
Dentoluux V
Dentoluux
Dentavit Monarch Acrotone Senator Dentorium
Dentorium Base Plate
Wrights Light Cure Tray Blanks
Dentorium
Dentavit
Alloy shots and rods Dentoweld
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Repack or Relabel Medical Device