Registered with FDA
HiSmile Pty Ltd
BURLEIGH WATERS, Australia. Lists 6 dental device types with FDA across 1 registered establishment.
- Device types listed
- 6
- Brands and models
- 7
- 510(k) clearances
- 0as applicant
- Markets registered in
- 1United States
- Establishments
- 1Australia
Devices listed with FDA
What HiSmile Pty Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Heat Source for Bleaching TeethEEG · Class 1 | Teeth whitening lights | Lister | Hismile LED Teeth Whitening Device, Sona Teeth Whitening Device (new), Smilehero Teeth Whitening KitHismile VIO405 Device, Hismile Professional Accelerator | 2018 |
| Over the Counter Denture CleanserEFT · Class 1 | Denture cleansers & adhesives | Lister | Hismile Germ Warfare Dental Appliance Cleaning Powder | 2026 |
| Manual ToothbrushEFW · Class 1 | Toothbrushes | Lister | HISMILE TOOTHBRUSH | 2023 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Lister | Mouth tray | 2018 |
| Powered ToothbrushJEQ · Class 1 | Toothbrushes | Lister | Hismile Electric Toothbrush | 2024 |
| Dental FlossJES · Class 1 | Floss & interdental cleaners | Lister | Hismile Waxed Floss | 2021 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| HISMILE PTY LTDFDA reg. 3014610038 | BURLEIGH WATERS Queensland, Australia | Foreign exporter, Private-label distributor |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10057830). 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.