Data / Medical devices / United Kingdom / Advanced Healthcare Ltd.
Advanced Healthcare Ltd.: FDA-registered device maker in TONBRIDGE Kent, United Kingdom, 11 510(k) clearances
Advanced Healthcare Ltd. is registered with the FDA (registration 8044038) in TONBRIDGE Kent, United Kingdom. It lists 5 device types. The FDA files 11 510(k) clearances under its listings, the newest dated March 18, 2022. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 8044038
- FEI number
- 3001027751
- Address
- Units 2-4, Leavers Estate Chiddingstone Causeway, TONBRIDGE Kent, United Kingdom, TN11 8JU
- Owner or operator
- ADVANCED HEALTHCARE LTD. (9005225)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- January 13, 1998
- Registered through
- 2027
- Brand names listed
- A59-0042, A59-0044, AHL Direct DIA (Diamond) Paste, AHL GENERIC REINFORCED ZINC OXIDE, EUGENOL CEMENT, GlasIonomer Cement CX-Plus, Glass Ionomer Aesthetic Restorative, Glass Ionomer Luting Cement Radiopa and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Agent, Tooth Bonding, Resin | KLE | 2 | Contract manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Zinc Oxide Eugenol | EMB | 1 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| March 18, 2022 | K213965 | BeautiBond Xtreme | KLE | Substantially Equivalent | Shofu Dental Corporation | accessdata.fda.gov |
| August 15, 2007 | K071742 | BEAUTIFIL II | EBF | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| March 21, 2003 | K024287 | FIXOBRIDGE 3-CEMENT | EMA | Substantially Equivalent | Advanced Healthcare , Ltd. | accessdata.fda.gov |
| January 31, 2003 | K023981 | AHL GENERIC GLASS IONOMER LUTING CEMENT | EMA | Substantially Equivalent | Advanced Healthcare , Ltd. | accessdata.fda.gov |
| April 9, 2002 | K020376 | AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE | EMA | Substantially Equivalent | Advanced Healthcare , Ltd. | accessdata.fda.gov |
| April 20, 2001 | K010914 | BEAUTIFIL | EBF | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| August 24, 1998 | K982461 | GLASIONOMER CEMENT CX PLUS | EMA | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| February 27, 1995 | K945451 | HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE | EMA | Substantially Equivalent | Shofu Dental Corp. | accessdata.fda.gov |
| May 27, 1993 | K931084 | TEMPIT | EMA | Substantially Equivalent | Centrix, Inc. | accessdata.fda.gov |
| August 10, 1992 | K922638 | TEMPIT-E | EMA | Substantially Equivalent | Centrix, Inc. | accessdata.fda.gov |
| May 19, 1986 | K861685 | SUPERLON (UNILON) CARBOXYLATE CEMENT | EMA | Substantially Equivalent | Carlisle Laboratories, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Cement, Dental
- All makers of Agent, Tooth Bonding, Resin
- All makers of Material, Tooth Shade, Resin
- All makers of Agent, Polishing, Abrasive, Oral Cavity
- All makers of Zinc Oxide Eugenol
Updated March 18, 2022. 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.