Manufacturer registered with FDA
Braebon Medical Corporation
KANATA, Canada. Lists 2 dental device types with FDA across 1 registered establishment.
- Device types listed
- 2
- Brands and models
- 3
- 510(k) clearances
- 0as applicant
- Markets registered in
- 8140 registrations outside the US
- Establishments
- 1Canada
Registered in 8 markets
Where regulators' registries name Braebon Medical Corporation 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 | Braebon Medical Corporation | 2 device types | — | Below |
| Canada | Health Canada | Registration holder | BRAEBON MEDICAL CORPORATION | 57 | 1999–2024 | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | BRAEBON Medical Corporation | 28 | — | Pure Global AI |
| European Union | EUDAMED | Registration holder | BRAEBON Medical Corporation | 25 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Braebon Medical Corporation | 20 | — | Pure Global AI |
| Australia | TGA | Manufacturer | Braebon Medical Corporation | 6 | 2022–2023 | Pure Global AI |
| South Korea | MFDS | Manufacturer | BRAEBON Medical Corporation | 3 | 2025–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BRAEBON MEDICAL CORPORATION | 1 | 2017–2017 | 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 Braebon Medical Corporation currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Mechanical Denture CleanerJER · Class 1 | Denture cleansers & adhesives | Maker | CPAPFreshOrthoFresh | 2023 |
| Anti-Snoring DeviceLRK · Class 2 | Anti-snoring & jaw-repositioning devices | Lister | SnoreByte | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Braebon Medical Corporation lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Craniofacial Pain Center of Idaho (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 16 Jul 2009 | K082849 | SILENT SLEEP | Craniofacial Pain Center of Idaho | LRK Anti-Snoring Device |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BRAEBON MEDICAL CORP.FDA reg. 3002912391 | KANATA Ontario, Canada | Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9041773). 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.