FDA Registration
Active
🇬🇧 United Kingdom
PSP DENTAL CO., LTD.
Reg #: 8021851
·
FEI: 1000254146
·
Expires 2026
Products
6
Proprietary Names
33
Establishment Types
4
Classifications
6
Registration Details
- Registration Name
- PSP DENTAL CO., LTD.
- Registration Number
- 8021851
- FEI Number
- 1000254146
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 3-5 DYLAN RD.
- City
- BELVEDERE, KENT
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K853093
Owner / Operator
- Firm Name
- PSP DENTAL CO., LTD.
- Operator Number
- 8021851
- Address
- 3-5 DYLAN RD., --
- City
- BELVEDERE, KENT
- State
- GB-NOTA
- Postal Code
- DA17 5QS
- Country
- GB
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Impression Tray, Resin | EBH | Class 1 | Dental | No | 2007-12-31 |
| Crown And Bridge, Temporary, Resin | EBG | Class 2 | Dental | No | 2007-12-31 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2007-12-31 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | Class 2 | Dental | No | 2007-12-31 |
| Zinc Oxide Eugenol | EMB | Class 1 | Dental | No | 1987-03-17 |
| Material, Impression | ELW | Class 2 | Dental | No | 2007-12-31 |
Proprietary Names
Temp Tray
Nucavfil
C&B Temp
Ceram II Powder/Liquid
Glass Ionomer Filling Material for Anterior Tooth (Powder/Liquid)
Ceramfil B Seasons
Ceramfil ART Powder
Glass Ionomer Filling Material
Fluricem
Florion
Ceramchem
Straticem
Ceramfil B
Ceramcore
Ceramfil Molar Powder/Liquid
Glass Ionomer filling Material
Glass Ionomer filling material for deciduous teeth (Atraumatic Restorative Technique)
Glass Ionomer filling Material (Powder/Liquid)
Emperor Comfdent
Emperor Refit
Emperor Periseal
Emperor 5/20
Emperor Comf-Dent
Emperor CC
Emperor Ortho
Emperor Std
TEMPLIN, TEMP D, NUCAVFIL
Super Algin
Alginamine
Ortho Algin
PSP Super Algin
Pro Algin Chromatic Alginate
Carbchem, Zinc Phosphate
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device for Another Party (Contract Manufacturer)
Repack or Relabel Medical Device
Manufacture Medical Device