Not currently registered with FDA under this name
Pentron Laboratory Technologies
Wallingford, CT, United States. Named as applicant on 5 dental 510(k) clearances between 2002 and 2003. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 52002–2003
- Markets registered in
- 3227 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 3 markets
Where regulators' registries name Pentron Laboratory Technologies 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 | Pentron Laboratory Technologies | 5 clearances | 2002–2003 | Below |
| Canada | Health Canada | Registration holder | PENTRON LABORATORY TECHNOLOGIES, LLC | 225 | 2002–2004 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Pentron Laboratory Technologies, LLC | 2 | 1999–1999 | 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 Pentron Laboratory Technologies as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 17 Jan 2003 | K023742 | SCULPTURE PLUS NANO-HYBRID COMPOSITE | EBF Resin Tooth Shade Material |
| 13 Jan 2003 | K023499 | GOLD CORE PLUS | EJH Base Metal Alloy |
| 18 Dec 2002 | K023502 | JEWEL CAST PLUS | EJH Base Metal Alloy |
| 18 Dec 2002 | K023501 | GOLD CORE 35 | EJT Gold-Based Noble Metal Alloy |
| 22 Apr 2002 | K020555 | SONATA MICRO HYBRID COMPOSITE | EBF Resin Tooth Shade Material |
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.