Manufacturer registered with FDA
Chewly Pty. Ltd.
Bellfield, Australia. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 2
- 510(k) clearances
- 0as applicant
- Markets registered in
- 21 registrations outside the US
- Establishments
- 1Australia
Registered in 2 markets
Where regulators' registries name Chewly Pty. Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Chewly Pty. Ltd. | 2 device types | — | Below |
| Australia | TGA | Registration holder | Chewly Pty Ltd | 1 | 2021–2021 | 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 Chewly 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 |
|---|---|---|---|---|
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | iChew | 2024 |
| Orthodontic Band SetterECR · Class 1 | Dental hand instruments | Maker | iChew Aligner Seater | 2024 |
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 |
|---|---|---|
| CHEWLY PTY. LTD.FDA reg. 3033590699 | Bellfield Victoria, Australia | Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10091898). 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.