Dental device manufacturers in Australia
19 companies have an FDA-registered establishment in Australia, across 19 sites. 13 manufacture dental devices there or own their specifications.
What they make
Retainers, expanders & headgear4Dental hand instruments4Impression trays3Denture resins & teeth2Implant instruments & surgical kits2Polishing & prophylaxis2Anti-snoring & jaw-repositioning devices2Temporary crown & bridge materials1Dental burs & diamonds1Oral irrigators1Denture cleansers & adhesives1Toothbrushes1Floss & interdental cleaners1Caries detection devices1
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Sdi Limited | Australia | Maker | Everfix · riva · Riva Bond LC · Riva Cem Automix · +79 | 8 | 2022 |
| Somnomed, Inc. | United States | Maker | Classic · Classic Lingual-Less · Flex · Fusion Classic · +16 | 11 | 2026 |
| Asiga | Australia | Maker | DentaTOOTH · DentaTRAY · DentaTRAY Orange · DentaBASE · +3 | 2 | 2025 |
| Myofunctional Research Co. Usa Inc. | United States | Maker | Bruxogard · Myobrace · Myoretainr · Myotalea · +8 | 3 | 2026 |
| Incisive Technologies Pty Ltd | Australia | Maker | BlueCheck | 1 | 2023 |
| Orthocell Limited | Australia | Maker | perFORM · Striate+ | 1 | 2021 |
| Erskine Dental | Australia | Maker | Hydropik · Hydropik Mini · Hydropik Pro · Hydropik Ultra · +18 | — | — |
| INKA Surgical Instruments | Australia | Maker | N/A | — | — |
| EOCA MD Pty Limited | Australia | Maker | Munchies · IPR Interproximal Reduction Burs · Munchies® VIBE · SpaceCHQR | — | — |
| Open Airway Dental Solutions | Australia | Maker | Device, anti-snoring · Device, anti-snoring - O2Vent Optima; O2Vent Optima Connect; O2Vent Optima Mini; O2Vent Optima Mini Connect · EHY / Tray, Impression, PREFORMED · EHY / Tray, Impression, PREFORMED - Oventus Bite Fork | — | — |
| Osteon Medical | Australia | Maker | DESS Dental Smart Solutions · Osteon Precision Milled Suprastructure · Osteon Scan Gauge Kit | — | — |
| Chewly Pty. Ltd. | Australia | Maker | iChew · iChew Aligner Seater | — | — |
| Baxter Laboratories | Australia | Maker | Pola Fresh Advanced Tooth Whitening and Cleansing Foam | — | — |
| ARTHREX Inc. | United States | Maker | AR-200 - Clips · Forceps, Rongeur, Surgical | — | — |
| HiSmile Pty Ltd | Australia | Foreign exporter | Hismile LED Teeth Whitening Device, Sona Teeth Whitening Device (new), Smilehero Teeth Whitening Kit · Hismile VIO405 Device, Hismile Professional Accelerator · Hismile Germ Warfare Dental Appliance Cleaning Powder · HISMILE TOOTHBRUSH · +3 | — | — |
| Jack And Jill Operations Pty Ltd. | Australia | Foreign exporter | Manual Toothbrush · Electric Toothbrush · Dental Floss · Dental Floss Pick · +2 | — | — |
| Steritech | Australia | Contract sterilizer | perFORM, MODEL perf1520, perf2030, perf3040 · Striate+, MODEL OCG-152, OCG-203, OCG-304, OCG-405 | — | — |
| Buzz Products Pty Ltd. | Australia | Foreign exporter | Dental Floss | — | — |
| CBE Pure Solutions Pty Ltd | Australia | Repacker / relabeler | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026