Not currently registered with FDA under this name
Pentron Clinical Technologies
Orange, CA, United States. Named as applicant on 13 dental 510(k) clearances between 2002 and 2009. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 132002–2009
- Markets registered in
- 654 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 6 markets
Where regulators' registries name Pentron Clinical 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 Clinical Technologies | 13 clearances | 2002–2009 | Below |
| Canada | Health Canada | Registration holder | PENTRON CLINICAL TECHNOLOGIES, LLC | 45 | 2004–2009 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Pentron Clinical Technologies, LLC | 4 | 1999–2005 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | PENTRON CLINICAL TECHNOLOGIES | 2 | — | Pure Global AI |
| Taiwan | TFDA | Manufacturer | PENTRON CLINICAL TECHNOLOGIES, LLC | 2 | 2005–2005 | Pure Global AI |
| Israel | AMAR | Manufacturer | PENTRON CLINICAL TECHNOLOGIES LLC | 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
510(k) clearances
Clearances on which FDA names Pentron Clinical Technologies as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 30 Oct 2009 | K091512 | BUILD-IT LIGHT CURE | EBF Resin Tooth Shade Material |
| 29 Aug 2008 | K081887 | LUTE-IT II VENEER CEMENT, MODEL NO6 | EMA Dental Cement |
| 4 Dec 2007 | K072830 | RM BOND, MODEL J032 | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 21 Nov 2007 | K072480 | GENERATION 8 SE ADHESIVE | KLE Resin Tooth Bonding Agent |
| 26 Oct 2007 | K072545 | ARTISTE SE FLOWABLE COMPOSITE, MODEL N280 | EBF Resin Tooth Shade Material |
| 10 Aug 2007 | K071500 | NANO-BOND II ADHESIVE SYSTEM | KLE Resin Tooth Bonding Agent |
| 27 Oct 2006 | K060889 | SE EPIPHANY ROOT CANAL SEALANT, MODEL N59SE | KIF Root Canal Filling Resin |
| 10 May 2006 | K060698 | CEMENT-IT ALL PURPOSE, MODEL N97 | EMA Dental Cement |
| 31 Oct 2005 | K052106 | SIMILE FLOW | EBF Resin Tooth Shade Material |
| 21 Oct 2005 | K052349 | AVANTE LED CURING UNIT, MODEL N44 | EBZ Ultraviolet Activator for Polymerization |
| 3 Apr 2003 | K023818 | FIBERFILL AGP | KIF Root Canal Filling Resin |
| 26 Mar 2003 | K023819 | FIBERFILL SGP | EKM Gutta-Percha |
| 21 Aug 2002 | K022150 | TRIONOMER | EMA Dental Cement |
Some of these clearances are listed with FDA today by another company: Sybron Dental Specialties (5), Rmo, Inc. (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.