FDA Registration
Active
🇬🇧 United Kingdom
ADVANCED HEALTHCARE LTD.
Reg #: 8044038
·
FEI: 3001027751
·
Expires 2026
Products
5
Proprietary Names
16
Establishment Types
4
Classifications
5
Registration Details
- Registration Name
- ADVANCED HEALTHCARE LTD.
- Registration Number
- 8044038
- FEI Number
- 3001027751
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- UNITS 2-4, LEAVERS ESTATE, CHIDDINGSTONE CAUSEWAY
- City
- TONBRIDGE Kent
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K071742
Owner / Operator
- Firm Name
- ADVANCED HEALTHCARE LTD.
- Operator Number
- 9005225
- Address
- UNITS 2-4, LEAVERS ESTATE, CHIDDINGSTONE CAUSEWAY
- City
- TONBRIDGE
- State
- Kent
- Postal Code
- TN11 8JU
- Country
- GB
- Correspondent
- Jeremy J Clarke
US Agent
- Business Name
- Rook Quality Systems
- Contact Name
- Tyler Ting
- Address
- 1155 Mount Vernon Hwy Ste 800
- City
- Dunwoody
- State
- GA
- ZIP
- 30338
- Country
- US
- [email protected]
- Phone
- 770 8330116
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Material, Tooth Shade, Resin | EBF | Class 2 | Dental | No | 2012-11-22 |
| Zinc Oxide Eugenol | EMB | Class 1 | Dental | No | 1998-01-13 |
| Cement, Dental | EMA | Class 2 | Dental | No | 2008-01-22 |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | Class 1 | Dental | No | 2008-02-14 |
| Agent, Tooth Bonding, Resin | KLE | Class 2 | Dental | No | 2023-11-09 |
Proprietary Names
EUGENOL CEMENT
AHL GENERIC REINFORCED ZINC OXIDE
Tempit E + Thin Tempit E (Centrix)
Temporary Dental Cement / Temp Luti
AHL Direct DIA (Diamond) Paste
Vivid OrthoLute Cement
Glass Ionomer Silver Reinforced (Al
Universal L/C Composite (Beautifil)
Glass Ionomer Luting Cement Radiopa
GlasIonomer Cement CX-Plus
Zinc Polycaboxylate Cements
Polycarboxylate Cement
A59-0042
Vivid Total Bond SE
A59-0044
Glass Ionomer Aesthetic Restorative
Establishment Types
Repack or Relabel Medical Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Export Device to the United States But Perform No Other Operation on Device