Manufacturer registered with FDA
Sdi Limited
BAYSWATER, VICTORIA, Australia. Lists 16 dental device types with FDA across 1 registered establishment, and holds 8 510(k) clearances as applicant.
- Device types listed
- 16
- Brands and models
- 99
- 510(k) clearances
- 82007–2022
- Markets registered in
- 7289 registrations outside the US
- Establishments
- 1Australia
510(k) clearances per year, 2000–2026
Registered in 7 markets
Where regulators' registries name Sdi Limited as the manufacturer or the registration holder of a device.
RegisteredHome: AustraliaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Sdi Limited | 8 clearances | 2007–2022 | Below |
| Colombia | INVIMA | Manufacturer | SDI LIMITED | 156 | — | Pure Global AI |
| Australia | TGA | Registration holder | SDI Ltd | 44 | 2004–2024 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | SDI LIMITEDSDI Limited | 39 | 2022–2025 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SDI LtdSDI Limited · SDI LIMITED | 34 | 2005–2023 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | SDI LIMITEDSDI LTD | 14 | 2008–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | SDI 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 Sdi Limited 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 | EverfixrivaRiva Bond LCRiva Cem AutomixRiva LC HVRiva Light CureRiva Light Cure HVRiva LutingRiva Luting PlusRiva SC HV 7 moreRiva Self CureRiva Self Cure HVRiva SilverSetSet PPZipbondZipbond Universal | 2007 |
| Resin Tooth Shade MaterialEBF · Class 2 | Dental composites | Maker | Acid Etch gelAcid Etch liquidAuraAura Bulk FillAura eASYFreedomGlacierIceLunaPAAMA 12 moreRiva LC HVRiva Light CureRiva Light Cure HVRokShade Modification KitStela Automix SystemStela Capsule SystemSuper EtchSuper Etch LVWaveWave HVWave MV | 2007 |
| Amalgam AlloyEJJ · Class 2 | — | Maker | Benco AdmixBenco SphericalGalloyGS 80GS 80 SphericalPD Admix AlloyPD SphericalPermitePermite CPL Admix Alloy 4 morePL SphericalPLA-96PPLS-96PUltracaps S | 2007 |
| Resin Tooth Bonding AgentKLE · Class 2 | Bonding agents | Maker | Adhesive 1AlloybondBonding ResinEtchant liquidFROGGoLokStaeStela Automix SystemStela Capsule System 2 moreZipbondZipbond Universal | 2007 |
| Pit and Fissure Sealant and ConditionerEBC · Class 2 | Sealants & varnishes | Maker | Conseal FConseal GreyConseal WhiteRiva CoatRiva ConditionerRiva LC HVRiva Light CureRiva Light Cure HVRiva Protect | 2007 |
| Cavity VarnishLBH · Class 2 | Sealants & varnishes | Maker | Adhesive 1FROGGoRiva Star | 2008 |
| Amalgam Dental CapsuleDZS · Class 1 | — | Maker | F400Lojic +Ultracaps | 1994 |
| Ultraviolet Activator for PolymerizationEBZ · Class 2 | Curing lights | Maker | Patterson BrandRadiiRadii CalRadii PlusRadii Xpert | 2007 |
| Ac-Powered Dental AmalgamatorEFD · Class 1 | — | Maker | Capsule MixerUltramat 2Ultramat S | 1994 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | — | 2022 |
| Oral Cavity Abrasive Polishing AgentEJR · Class 1 | Polishing & prophylaxis | Maker | Polishing Paste | 2014 |
| MercuryELY · Class 2 | — | Maker | Ultracaps S | 2008 |
| Resin ApplicatorKXR · Class 1 | — | Maker | Complet ApplicatorPointsRiva ApplicatorRiva Applicator 2Riva Applicator 2 Black | 2014 |
| Dental Stain EraserMAU · Class 1 | — | Maker | Pola Fresh | 2026 |
| Dental AmalgamOIV · Class 2 | — | Maker | Ultracaps S | 2008 |
| Diammine Silver Fluoride Dental Hypersensitivity VarnishPHR · Class 2 | — | Maker | Riva Star | 2019 |
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 Sdi Limited as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 28 Oct 2022 | K222583 | Stela Capsule System | EBF Resin Tooth Shade Material |
| 28 Oct 2022 | K222581 | Stela Automix System | EBF Resin Tooth Shade Material |
| 30 Aug 2022 | K214118 | Riva Cem Automix | EMA Dental Cement |
| 2 Dec 2019 | K191656 | Zipbond | KLE Resin Tooth Bonding Agent |
| 11 Apr 2018 | K172047 | Riva Star | PHR Diammine Silver Fluoride Dental Hypersensitivity Varnish |
| 8 Dec 2010 | K102984 | AURA | EBF Resin Tooth Shade Material |
| 10 Jul 2008 | K081273 | ULTRACAPS S | OIV Dental Amalgam |
| 14 Dec 2007 | K073043 | SET PP | EMA Dental Cement |
Also lists devices cleared under other names
Sdi Limited 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: Southern Dental Industries, Inc. (24).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 15 Nov 2006 | K062065 | RIVA LUTING PLUS | Southern Dental Industries, Inc. | EMA Dental Cement |
| 9 Nov 2006 | K062064 | RIVA BOND LC | Southern Dental Industries, Inc. | EMA Dental Cement |
| 15 Jun 2005 | K051008 | SET | Southern Dental Industries, Inc. | EMA Dental Cement |
| 10 Jun 2005 | K050871 | RIVA PROTECT | Southern Dental Industries, Inc. | EBC Pit and Fissure Sealant and Conditioner |
| 3 Jun 2005 | K050870 | RIVA LIGHT CURE | Southern Dental Industries, Inc. | EMA Dental Cement |
| 24 Mar 2005 | K050331 | ADHESIVE 1 | Southern Dental Industries, Inc. | KLE Resin Tooth Bonding Agent |
| 7 Dec 2004 | K042452 | RIVA SILVER | Southern Dental Industries, Inc. | EMA Dental Cement |
| 30 Apr 2004 | K040393 | RIVA LUTING | Southern Dental Industries, Inc. | EMA Dental Cement |
| 6 Aug 2003 | K032152 | BENCO ADMIX | Southern Dental Industries, Inc. | EJJ Amalgam Alloy |
| 29 Jul 2003 | K031658 | BENCO SPHERICAL | Southern Dental Industries, Inc. | EJJ Amalgam Alloy |
| 24 Apr 2003 | K030568 | RADII | Southern Dental Industries, Inc. | EBZ Ultraviolet Activator for Polymerization |
| 17 Apr 2003 | K030516 | RIVA-SELF CURE | Southern Dental Industries, Inc. | EMA Dental Cement |
| 22 Oct 2001 | K012528 | ICE | Southern Dental Industries, Inc. | EBF Resin Tooth Shade Material |
| 22 Oct 2001 | K012529 | ROK | Southern Dental Industries, Inc. | EBF Resin Tooth Shade Material |
| 14 May 1999 | K990650 | CONSEAL F | Southern Dental Industries, Inc. | EBC Pit and Fissure Sealant and Conditioner |
| 16 Jun 1998 | K981383 | ALLOYBOND | Southern Dental Industries, Inc. | KLE Resin Tooth Bonding Agent |
| 8 Dec 1997 | K973091 | WAVE | Southern Dental Industries, Inc. | EBF Resin Tooth Shade Material |
| 8 Dec 1997 | K973092 | STAE | Southern Dental Industries, Inc. | KLE Resin Tooth Bonding Agent |
| 8 Dec 1997 | K973089 | FREEDOM | Southern Dental Industries, Inc. | EBF Resin Tooth Shade Material |
| 7 Oct 1997 | K973086 | PLA-96P | Southern Dental Industries, Inc. | EJJ Amalgam Alloy |
| 3 Oct 1997 | K973088 | PLS-96P | Southern Dental Industries, Inc. | EJJ Amalgam Alloy |
| 24 Jan 1996 | K955285 | GALLOY | Southern Dental Industries, Inc. | EJJ Amalgam Alloy |
| 5 Jul 1994 | K941899 | SDI COMPOSTIES | Southern Dental Industries, Inc. | EBF Resin Tooth Shade Material |
| 27 Aug 1980 | K801639 | PERMITE DENTAL AMALGAM ALLOY | Southern Dental Industries, Inc. | EJJ Amalgam Alloy |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SDI LTD.FDA reg. 3004140838 | BAYSWATER Victoria, Australia | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9002445). 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.