Manufacturer registered with FDA
Advanced Healthcare , Ltd.
TONBRIDGE, United Kingdom. Lists 5 dental device types with FDA across 1 registered establishment, and holds 3 510(k) clearances as applicant.
- Device types listed
- 5
- Brands and models
- 17
- 510(k) clearances
- 32002–2003
- Markets registered in
- 36 registrations outside the US
- Establishments
- 1United Kingdom
510(k) clearances per year, 2000–2026
Registered in 3 markets
Where regulators' registries name Advanced Healthcare , Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Advanced Healthcare , Ltd. | 3 clearances | 2002–2003 | Below |
| Taiwan | TFDA | Manufacturer | ADVANCED HEALTHCARE LTDADVANCED HEALTHCARE LTD. | 4 | 2011–2021 | Pure Global AI |
| Israel | AMAR | Manufacturer | Advanced Healthcare Ltd | 2 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Advanced Healthcare , Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Dental CementEMA · Class 2 | Dental cements | Maker | GlasIonomer Cement CX-PlusGlass Ionomer Aesthetic RestorativeGlass Ionomer Luting Cement RadiopaGlass Ionomer Silver Reinforced (AlPolycarboxylate CementTempit E + Thin Tempit E (Centrix)Temporary Dental Cement / Temp LutiVivid OrthoLute CementZinc Polycaboxylate Cements | 2008 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Glass Ionomer Aesthetic RestorativeUniversal L/C Composite (Beautifil) | 2008 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | A59-0042A59-0044Vivid Total Bond SE | 2013 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | AHL Direct DIA (Diamond) Paste | 2008 |
| Zinc Oxide EugenolEMB · Class 1 | Dental cements | Maker | AHL GENERIC REINFORCED ZINC OXIDEEUGENOL CEMENT | 1998 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Advanced Healthcare , Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 21 Mar 2003 | K024287 | FIXOBRIDGE 3-CEMENT | EMA Dental Cement |
| 31 Jan 2003 | K023981 | AHL GENERIC GLASS IONOMER LUTING CEMENT | EMA Dental Cement |
| 9 Apr 2002 | K020376 | AHL GENERIC GLASS IONOMER AESTHETIC RESTORATIVE | EMA Dental Cement |
Some of these clearances are listed with FDA today by another company: DOC BRANDS, Inc. (1), Centrix, Inc. (1).
Also lists devices cleared under other names
Advanced Healthcare , Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Shofu Inc (5), Centrix, Inc. (2), Carlisle Laboratories, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 18 Mar 2022 | K213965 | BeautiBond Xtreme | Shofu Inc | KLE Resin Tooth Bonding Agent |
| 15 Aug 2007 | K071742 | BEAUTIFIL II | Shofu Inc | EBF Resin Tooth Shade Material |
| 20 Apr 2001 | K010914 | BEAUTIFIL | Shofu Inc | EBF Resin Tooth Shade Material |
| 24 Aug 1998 | K982461 | GLASIONOMER CEMENT CX PLUS | Shofu Inc | EMA Dental Cement |
| 27 Feb 1995 | K945451 | HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE | Shofu Inc | EMA Dental Cement |
| 27 May 1993 | K931084 | TEMPIT | Centrix, Inc. | EMA Dental Cement |
| 10 Aug 1992 | K922638 | TEMPIT-E | Centrix, Inc. | EMA Dental Cement |
| 19 May 1986 | K861685 | SUPERLON (UNILON) CARBOXYLATE CEMENT | Carlisle Laboratories, Inc. | EMA Dental Cement |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| ADVANCED HEALTHCARE LTD.FDA reg. 8044038 | TONBRIDGE Kent, United Kingdom | Contract manufacturer, Foreign exporter, Manufacturer, Repacker / relabeler |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9005225). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.