Not currently registered with FDA under this name

Pentron Clinical

Orange, CA, United States. Named as applicant on 4 dental 510(k) clearances between 2011 and 2013. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
42011–2013
Markets registered in
770 registrations outside the US
Establishments
0—
2011: 22012: 12013: 120102020

510(k) clearances per year, 2007–2026

Registered in 7 markets

Where regulators' registries name Pentron Clinical as the manufacturer or the registration holder of a device.

All markets
United States: 4 clearancesSaudi Arabia: 29 registrationsTaiwan: 18 registrationsColombia: 10 registrationsIsrael: 7 registrationsAustralia: 5 registrationsPeru: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantPentron Clinical4 clearances2011–2013Below
Saudi ArabiaSFDAManufacturerPentron Clinical29—Pure Global AI
TaiwanTFDAManufacturerPENTRON CLINICAL182005–2024Pure Global AI
ColombiaINVIMARegistration holderPENTRON CLINICAL10—Pure Global AI
IsraelAMARManufacturerPentron ClinicalPENTRON CLINICAL7—Pure Global AI
AustraliaTGAManufacturerPentron Clinical52010–2016Pure Global AI
PeruDIGEMIDManufacturerPENTRON CLINICAL12023–2023Pure 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 as the applicant.

Decided510(k)DeviceDevice type
2 Jul 2013K130920CORRECT PLUS 1ELW Impression Material
22 May 2012K120013TEMPSPAN CLEAR MATRIXELW Impression Material
1 Aug 2011K111431B1P ADHESIVEKLE Resin Tooth Bonding Agent
5 Jan 2011K102703BUILD-IT TOTAL COREEBF Resin Tooth Shade Material

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.