Not currently registered with FDA under this name
Southern Dental Industries, Inc.
Bayswater Vi 3125, Australia. Named as applicant on 24 dental 510(k) clearances between 1980 and 2006. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 241980–2006
- Markets registered in
- 28 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 2 markets
Where regulators' registries name Southern Dental Industries, Inc. 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 | Southern Dental Industries, Inc. | 24 clearances | 1980–2006 | Below |
| South Korea | MFDS | Manufacturer | Southern Dental Industries LtdSouthern Dental Industries · Southern Dental Industries Ltd. | 8 | 1999–2003 | 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 Southern Dental Industries, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 15 Nov 2006 | K062065 | RIVA LUTING PLUS | EMA Dental Cement |
| 9 Nov 2006 | K062064 | RIVA BOND LC | EMA Dental Cement |
| 15 Jun 2005 | K051008 | SET | EMA Dental Cement |
| 10 Jun 2005 | K050871 | RIVA PROTECT | EBC Pit and Fissure Sealant and Conditioner |
| 3 Jun 2005 | K050870 | RIVA LIGHT CURE | EMA Dental Cement |
| 24 Mar 2005 | K050331 | ADHESIVE 1 | KLE Resin Tooth Bonding Agent |
| 7 Dec 2004 | K042452 | RIVA SILVER | EMA Dental Cement |
| 30 Apr 2004 | K040393 | RIVA LUTING | EMA Dental Cement |
| 6 Aug 2003 | K032152 | BENCO ADMIX | EJJ Amalgam Alloy |
| 29 Jul 2003 | K031658 | BENCO SPHERICAL | EJJ Amalgam Alloy |
| 24 Apr 2003 | K030568 | RADII | EBZ Ultraviolet Activator for Polymerization |
| 17 Apr 2003 | K030516 | RIVA-SELF CURE | EMA Dental Cement |
| 22 Oct 2001 | K012529 | ROK | EBF Resin Tooth Shade Material |
| 22 Oct 2001 | K012528 | ICE | EBF Resin Tooth Shade Material |
| 14 May 1999 | K990650 | CONSEAL F | EBC Pit and Fissure Sealant and Conditioner |
| 16 Jun 1998 | K981383 | ALLOYBOND | KLE Resin Tooth Bonding Agent |
| 8 Dec 1997 | K973092 | STAE | KLE Resin Tooth Bonding Agent |
| 8 Dec 1997 | K973091 | WAVE | EBF Resin Tooth Shade Material |
| 8 Dec 1997 | K973089 | FREEDOM | EBF Resin Tooth Shade Material |
| 7 Oct 1997 | K973086 | PLA-96P | EJJ Amalgam Alloy |
| 3 Oct 1997 | K973088 | PLS-96P | EJJ Amalgam Alloy |
| 24 Jan 1996 | K955285 | GALLOY | EJJ Amalgam Alloy |
| 5 Jul 1994 | K941899 | SDI COMPOSTIES | EBF Resin Tooth Shade Material |
| 27 Aug 1980 | K801639 | PERMITE DENTAL AMALGAM ALLOY | EJJ Amalgam Alloy |
Some of these clearances are listed with FDA today by another company: Sdi Limited (24).
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.