Not currently registered with FDA under this name
Ab Ardent
Amherst, NY, United States. Named as applicant on 13 dental 510(k) clearances between 1998 and 2013. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 131998–2013
- Markets registered in
- 314 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 3 markets
Where regulators' registries name Ab Ardent as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Ab Ardent | 13 clearances | 1998–2013 | Below |
| South Korea | MFDS | Manufacturer | AB ArdentAB ARDENT | 11 | 2000–2006 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | AB Ardent | 3 | — | 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
510(k) clearances
Clearances on which FDA names Ab Ardent as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 14 Nov 2013 | K131753 | MERIDIAN | EBF Resin Tooth Shade Material |
| 20 Jul 2004 | K040465 | LATIT FLOW | EBF Resin Tooth Shade Material |
| 25 Nov 2002 | K022971 | MICROHYBRID 11 | EBF Resin Tooth Shade Material |
| 22 Nov 2002 | K022975 | ETCHING 15 | EBF Resin Tooth Shade Material |
| 22 Nov 2002 | K022974 | MICROHYBRID 12 | EBF Resin Tooth Shade Material |
| 22 Nov 2002 | K022973 | ADHESIVE 14 | KLE Resin Tooth Bonding Agent |
| 22 Nov 2002 | K022972 | MICROFILL 13 | EBF Resin Tooth Shade Material |
| 7 May 2002 | K020452 | HIGH SILVER CONVENTIONAL | EJJ Amalgam Alloy |
| 16 Aug 2001 | K011801 | FUTURA TOPCAP NON GAMMA-2 | EJJ Amalgam Alloy |
| 17 Sep 1999 | K991974 | FUTURA GLASS IONOMER SILVER REINFORCED | EMA Dental Cement |
| 24 Aug 1998 | K982460 | VIVACAP HR | EJJ Amalgam Alloy |
| 24 Aug 1998 | K982458 | VIVALLOY HR | EJJ Amalgam Alloy |
| 24 Aug 1998 | K982456 | AMALCAP PLUS | EJJ Amalgam Alloy |
Sources
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 of the most recent filing, which can be a US agent.