Not currently registered with FDA under this name
Pac-Dent International, Inc.
Brea, CA, United States. Named as applicant on 4 dental 510(k) clearances between 2013 and 2015. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 42013–2015
- Markets registered in
- 415 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name Pac-Dent International, Inc. 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 | Pac-Dent International, Inc. | 4 clearances | 2013–2015 | Below |
| South Korea | MFDS | Manufacturer | Pac-Dent International, Inc.Pac-Dent International,Inc. | 11 | 2005–2010 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | PAC-DENT INTERNATIONAL, INC. | 3 | 2009–2009 | Pure Global AI |
| Australia | TGA | Manufacturer | Pac Dent International Inc | 1 | 2010–2010 | 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 Pac-Dent International, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 28 Jul 2015 | K151150 | Elements | ELW Impression Material |
| 9 Mar 2015 | K141717 | PACSEAL PIT & FISSURE SEALANT | EBC Pit and Fissure Sealant and Conditioner |
| 30 Sep 2014 | K141422 | PROFLUORO FLUORIDE VARNISH | LBH Cavity Varnish |
| 13 Aug 2013 | K130672 | OPTIFLOW II FLOWABLE COMPOSITE, LC | EBF Resin Tooth Shade Material |
Some of these clearances are listed with FDA today by another company: Pac-Dent Inc. (2), IPB Inc (1), Specialty Appliances, LLC (1), The Belport Company, Inc. DBA Gingi-Pak (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.