Not currently registered with FDA under this name

Kensey Nash Corporation

Exton, PA, United States. Named as applicant on 3 dental 510(k) clearances between 2009 and 2013. No establishment is registered with FDA under this exact name today.

Device types listed
0
Brands and models
0
510(k) clearances
32009–2013
Markets registered in
32 registrations outside the US
Establishments
0—
2009: 22013: 1200020102020

510(k) clearances per year, 2000–2026

Registered in 3 markets

Where regulators' registries name Kensey Nash Corporation as the manufacturer or the registration holder of a device.

All markets
United States: 3 clearancesIsrael: 1 registrationsTaiwan: 1 registrations
RegisteredHome: United StatesOne marker per market
MarketRegulatorNamed asName on the registryRegistrationsIssuedRecords
United StatesFDAApplicantKensey Nash Corporation3 clearances2009–2013Below
IsraelAMARManufacturerKENSEY NASH CO.1—Pure Global AI
TaiwanTFDAManufacturerKENSEY NASH CORPORATION12003–2003Pure 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 Kensey Nash Corporation as the applicant.

Decided510(k)DeviceDevice type
11 Jul 2013K121310MESOTHELIUM DENTAL MEMBRANENPL Intraoral Animal Source Barrier
2 Nov 2009K091192KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XXNPL Intraoral Animal Source Barrier
2 Oct 2009K090919KENSEY NASH FIBRILLAR COLLAGEN DENTAL MEMBRANENPL Intraoral Animal Source Barrier

Some of these clearances are listed with FDA today by another company: Dsm Biomedical (2), Young Innovations 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.