Data / Medical devices / Australia / Sdi Ltd.
Sdi Ltd.: FDA-registered device maker in BAYSWATER Victoria, Australia, 32 510(k) clearances
Sdi Ltd. is registered with the FDA (registration 3004140838) in BAYSWATER Victoria, Australia. It lists 16 device types. The FDA files 32 510(k) clearances under its listings, the newest dated October 28, 2022. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3004140838
- Address
- 3-15 Brunsdon ST., BAYSWATER Victoria, Australia, 3153
- Owner or operator
- SDI LTD. (9002445)
- Roles
- Manufacturer
- First device listed
- May 2, 1994
- Registered through
- 2026
- Brand names listed
- Acid Etch gel, Acid Etch liquid, Adhesive 1, Alloybond, Aura, Aura Bulk Fill, Aura eASY, Benco Admix and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Activator, Ultraviolet, For Polymerization | EBZ | 2 | Manufacturer | accessdata.fda.gov |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Manufacturer | accessdata.fda.gov |
| Agent, Tooth Bonding, Resin | KLE | 2 | Manufacturer | accessdata.fda.gov |
| Alloy, Amalgam | EJJ | 2 | Manufacturer | accessdata.fda.gov |
| Amalgamator, Dental, Ac-Powered | EFD | 1 | Manufacturer | accessdata.fda.gov |
| Applicator, Resin | KXR | 1 | Manufacturer | accessdata.fda.gov |
| Capsule, Dental, Amalgam | DZS | 1 | Manufacturer | accessdata.fda.gov |
| Cement, Dental | EMA | 2 | Manufacturer | accessdata.fda.gov |
| Dam, Rubber | EIE | 1 | Manufacturer | accessdata.fda.gov |
| Dental Amalgam | OIV | 2 | Manufacturer | accessdata.fda.gov |
| Diammine Silver Fluoride Dental Hypersensitivity Varnish | PHR | 2 | Manufacturer | accessdata.fda.gov |
| Eraser, Dental Stain | MAU | 1 | Manufacturer | accessdata.fda.gov |
| Material, Tooth Shade, Resin | EBF | 2 | Manufacturer | accessdata.fda.gov |
| Mercury | ELY | 2 | Manufacturer | accessdata.fda.gov |
| Sealant, Pit And Fissure, And Conditioner | EBC | 2 | Manufacturer | accessdata.fda.gov |
| Varnish, Cavity | LBH | 2 | 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 |
|---|---|---|---|---|---|---|
| October 28, 2022 | K222583 | Stela Capsule System | EBF | Substantially Equivalent | Sdi Limited | accessdata.fda.gov |
| October 28, 2022 | K222581 | Stela Automix System | EBF | Substantially Equivalent | Sdi Limited | accessdata.fda.gov |
| August 30, 2022 | K214118 | Riva Cem Automix | EMA | Substantially Equivalent | Sdi Limited | accessdata.fda.gov |
| December 2, 2019 | K191656 | Zipbond | KLE | Substantially Equivalent | Sdi Limited | accessdata.fda.gov |
| April 11, 2018 | K172047 | Riva Star | PHR | Substantially Equivalent | Sdi Limited | accessdata.fda.gov |
| December 8, 2010 | K102984 | AURA | EBF | Substantially Equivalent | Sdi Limited | accessdata.fda.gov |
| July 10, 2008 | K081273 | ULTRACAPS S | OIV | Substantially Equivalent | Sdi , Ltd. | accessdata.fda.gov |
| December 14, 2007 | K073043 | SET PP | EMA | Substantially Equivalent | Sdi , Ltd. | accessdata.fda.gov |
| November 15, 2006 | K062065 | RIVA LUTING PLUS | EMA | Substantially Equivalent | Southern Dental Industries, Inc. | accessdata.fda.gov |
| November 9, 2006 | K062064 | RIVA BOND LC | EMA | Substantially Equivalent | Southern Dental Industries, Inc. | accessdata.fda.gov |
| June 15, 2005 | K051008 | SET | EMA | Substantially Equivalent | Southern Dental Industries, Ltd. | accessdata.fda.gov |
| June 10, 2005 | K050871 | RIVA PROTECT | EBC | Substantially Equivalent | Southern Dental Industries, Inc. | accessdata.fda.gov |
| June 3, 2005 | K050870 | RIVA LIGHT CURE | EMA | Substantially Equivalent | Southern Dental Industries, Inc. | accessdata.fda.gov |
| March 24, 2005 | K050331 | ADHESIVE 1 | KLE | Substantially Equivalent | Southern Dental Industries, Inc. | accessdata.fda.gov |
| December 7, 2004 | K042452 | RIVA SILVER | EMA | Substantially Equivalent | Southern Dental Industries, Inc. | accessdata.fda.gov |
| April 30, 2004 | K040393 | RIVA LUTING | EMA | Substantially Equivalent | Southern Dental Industries, Inc. | accessdata.fda.gov |
| August 6, 2003 | K032152 | BENCO ADMIX | EJJ | Substantially Equivalent | Southern Dental Industries, Inc. | accessdata.fda.gov |
| July 29, 2003 | K031658 | BENCO SPHERICAL | EJJ | Substantially Equivalent | Southern Dental Industries, Inc. | accessdata.fda.gov |
| April 24, 2003 | K030568 | RADII | EBZ | Substantially Equivalent | Southern Dental Industries, Inc. | accessdata.fda.gov |
| April 17, 2003 | K030516 | RIVA-SELF CURE | EMA | Substantially Equivalent | Southern Dental Industries, Inc. | accessdata.fda.gov |
| October 22, 2001 | K012529 | ROK | EBF | Substantially Equivalent | Southern Dental Industries, Ltd. | accessdata.fda.gov |
| October 22, 2001 | K012528 | ICE | EBF | Substantially Equivalent | Southern Dental Industries, Ltd. | accessdata.fda.gov |
| May 14, 1999 | K990650 | CONSEAL F | EBC | Substantially Equivalent | Southern Dental Industries, Inc. | accessdata.fda.gov |
| June 16, 1998 | K981383 | ALLOYBOND | KLE | Substantially Equivalent | Southern Dental Industries, Inc. | accessdata.fda.gov |
| December 8, 1997 | K973092 | STAE | KLE | Substantially Equivalent | Southern Dental Industries, Inc. | accessdata.fda.gov |
| December 8, 1997 | K973091 | WAVE | EBF | Substantially Equivalent | Southern Dental Industries, Inc. | accessdata.fda.gov |
| December 8, 1997 | K973089 | FREEDOM | EBF | Substantially Equivalent | Southern Dental Industries, Inc. | accessdata.fda.gov |
| October 7, 1997 | K973086 | PLA-96P | EJJ | Substantially Equivalent | Southern Dental Industries, Inc. | accessdata.fda.gov |
| October 3, 1997 | K973088 | PLS-96P | EJJ | Substantially Equivalent | Southern Dental Industries, Inc. | accessdata.fda.gov |
| January 24, 1996 | K955285 | GALLOY | EJJ | Substantially Equivalent | Southern Dental Industries, Inc. | accessdata.fda.gov |
| July 5, 1994 | K941899 | SDI COMPOSTIES | EBF | Substantially Equivalent | Southern Dental Industries, Inc. | accessdata.fda.gov |
| August 27, 1980 | K801639 | PERMITE DENTAL AMALGAM ALLOY | EJJ | Substantially Equivalent | Southern Dental Industries, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 20, 2026 | 99322 | Class II | Ongoing | Dentsply Sirona Capsule Mixer Model No. 5546068 | Potential for electrical discharge from unit when unplugged. | accessdata.fda.gov |
Compare with other makers
- All makers of Dam, Rubber
- All makers of Applicator, Resin
- All makers of Material, Tooth Shade, Resin
- All makers of Alloy, Amalgam
- All makers of Agent, Tooth Bonding, Resin
- All makers of Cement, Dental
Updated August 14, 2026. 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.