Not currently registered with FDA under this name

Organogenesis, Inc.

Canton, MA, United States. Named as applicant on 1 dental 510(k) clearance between 2007 and 2007. No establishment is registered with FDA under this exact name today.

Device types listed: 0
Brands and models: 0
510(k) clearances: 12007–2007
Markets registered in: 32 registrations outside the US
Establishments: 0—

510(k) clearances per year, 2000–2026

Registered in 3 markets

Where regulators' registries name Organogenesis, Inc. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: United StatesOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Applicant	Organogenesis, Inc.	1 clearances	2007–2007	Below
Canada	Health Canada	Registration holder	ORGANOGENESIS INC.	1	2012–2012	Pure Global AI
Saudi Arabia	SFDA	Manufacturer	Organogenesis Inc.	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 Organogenesis, Inc. as the applicant.

Decided	510(k)	Device	Device type
30 Aug 2007	K071555	FORTAGEN ORAL MEMBRANE	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.