Not currently registered with FDA under this name

Kerecis

Isafjordur, Iceland. Named as applicant on 2 dental 510(k) clearances between 2020 and 2022. No establishment is registered with FDA under this exact name today.

1 clearance in five years

Device types listed: 0
Brands and models: 0
510(k) clearances: 22020–2022
Markets registered in: 725 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2007–2026

Registered in 7 markets

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

All markets

RegisteredHome: IcelandOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Kerecis	2 clearances	2020–2022	Below
Canada	Health Canada	Registration holder	KERECIS AGKERECIS LIMITED	9	2012–2026	Pure Global AI
European Union	EUDAMED	Manufacturer	Kerecis Limited	8	—	Pure Global AI
Australia	TGA	Manufacturer	Kerecis LimitedKerecis AG	4	2022–2026	Pure Global AI
United Kingdom	MHRA	Manufacturer	Kerecis Limited	2	—	Pure Global AI
South Korea	MFDS	Manufacturer	Kerecis Limited	1	2018–2018	Pure Global AI
Taiwan	TFDA	Manufacturer	Kerecis Ltd.	1	2018–2018	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 Kerecis as the applicant.

Decided	510(k)	Device	Device type
30 Sep 2022	K213904	Kerecis Oral	NPL Intraoral Animal Source Barrier
13 Nov 2020	K192612	Kerecis Gingiva Graft	NPL Intraoral Animal Source Barrier

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.