Manufacturer registered with FDA
EOCA MD Pty Limited
Double Bay, Australia. Lists 4 dental device types with FDA across 1 registered establishment.
- Device types listed
- 4
- Brands and models
- 4
- 510(k) clearances
- 0as applicant
- Markets registered in
- 416 registrations outside the US
- Establishments
- 1Australia
Registered in 4 markets
Where regulators' registries name EOCA MD Pty Limited 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 | EOCA MD Pty Limited | 4 device types | — | Below |
| European Union | EUDAMED | Manufacturer | EOCA MD Pty Ltd | 10 | — | Pure Global AI |
| Australia | TGA | Manufacturer | EOCA MD Pty Ltd | 5 | 2015–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | EOCA MD Pty Limited | 1 | — | 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 EOCA MD Pty 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 |
|---|---|---|---|---|
| Orthodontic Space Preformed MaintainerDYT · Class 1 | Retainers, expanders & headgear | Maker | Munchies | 2015 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | IPR Interproximal Reduction Burs | 2024 |
| Orthodontic Band SetterECR · Class 1 | Dental hand instruments | Maker | Munchies® VIBE | 2020 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | SpaceCHQR | 2022 |
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 |
|---|---|---|
| EOCA MD PTY LIMITEDFDA reg. 3011575061 | Double Bay New South Wales, Australia | Manufacturer, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10048955). 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.