Not currently registered with FDA under this name
Germiphene Corp.
Brantford, Ont, Canada. Named as applicant on 4 dental 510(k) clearances between 1989 and 1998. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 41989–1998
- Markets registered in
- 616 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1980–2026
Registered in 6 markets
Where regulators' registries name Germiphene Corp. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Germiphene Corp. | 4 clearances | 1989–1998 | Below |
| Canada | Health Canada | Registration holder | GERMIPHENE CORPORATION | 5 | 2007–2021 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | GERMIPHENE CORPORATIONGERMIPHENE | 5 | 2007–2018 | Pure Global AI |
| Australia | TGA | Manufacturer | Germiphene Corp | 2 | 2011–2016 | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Germiphene Corporation | 2 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Germiphene Corporation | 2 | 2004–2006 | 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
510(k) clearances
Clearances on which FDA names Germiphene Corp. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 1 Dec 1998 | K983847 | MODIFICATION OF: ODYSSEY I DENTAL WATER UNIT | EIA Operative Dental Unit |
| 14 May 1997 | K964796 | ODYSSEY I DENTAL WATER UNIT | EIA Operative Dental Unit |
| 4 Nov 1994 | K942851 | SMILE INTEGRATED PROPHYLAXIS PASTE RINGS | EJR Oral Cavity Abrasive Polishing Agent |
| 12 Oct 1989 | K894933 | PERLIDENT | EJR Oral Cavity Abrasive Polishing Agent |
Sources
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 of the most recent filing, which can be a US agent.