Not currently registered with FDA under this name
Sybron Endo
Orange, CA, United States. Named as applicant on 1 dental 510(k) clearance between 2014 and 2014. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12014–2014
- Markets registered in
- 595 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 5 markets
Where regulators' registries name Sybron Endo 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 | Sybron Endo | 1 clearances | 2014–2014 | Below |
| Saudi Arabia | SFDA | Manufacturer | SybronEndo | 75 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Sybron Endo | 9 | 2005–2006 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | SYBRONENDOSYBRONENDO CORPORATION | 9 | 2006–2018 | Pure Global AI |
| Israel | AMAR | Manufacturer | SYBRONENDO | 2 | — | 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 Sybron Endo as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 2 Jul 2014 | K140685 | ENDO VAC APICAL NEGATIVE PRESSURE IRIGATION SYSTEM | NYL Root Canal Irrigation Air-Powered Handpiece |
Some of these clearances are listed with FDA today by another company: Sybron Dental Specialties (1).
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.