Data / Medical devices / Germany / Curasan AG, Frankfurt Facility

Curasan AG, Frankfurt Facility: FDA-registered device maker in FRANKFURT Hesse, Germany, 7 510(k) clearances

Name: Curasan AG, Frankfurt Facility FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Curasan AG, Frankfurt Facility is registered with the FDA (registration 3004847139) in FRANKFURT Hesse, Germany. It lists 2 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 17, 2018. Registered through 2026. FDA data exported November 3, 2026.

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Get makers like this one Watch Curasan AG, Frankfurt Facility

FDA registration number: 3004847139
Address: Ernst-Wiss-Strasse 18, FRANKFURT Hesse, Germany, 65933
Owner or operator: curasan AG (10034158)
Roles: Manufacturer
First device listed: November 11, 2010
Registered through: 2026
Brand names listed: CERASORB Bioactive, Ceracell Dental, Ceracell Ortho Foam, Cerasorb Dental, Cerasorb M Ortho Granules, Cerasorb Ortho Foam, IngeniOs Beta-TCP Bioactive, IngeniOs HA and more

Devices it lists

Device	Product code	Class	Role	Source
Bone Grafting Material, Synthetic	LYC	2	Manufacturer	accessdata.fda.gov
Filler, Bone Void, Calcium Compound	MQV	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
September 17, 2018	K181721	Ceracell Ortho Foam	MQV	Substantially Equivalent	Curasan AG	accessdata.fda.gov
December 2, 2016	K160566	Cerasorb Ortho Foam	MQV	Substantially Equivalent	Curasan AG	accessdata.fda.gov
December 20, 2012	K111105	CURASAN OSSEOLIVE DENTAL	LYC	Substantially Equivalent	Curasan AG	accessdata.fda.gov
March 10, 2011	K103709	CERACELL DENTAL	LYC	Substantially Equivalent	Curasan AG	accessdata.fda.gov
January 12, 2011	K102872	OSBONE DENTAL	LYC	Substantially Equivalent	Curasan AG	accessdata.fda.gov
July 22, 2005	K051443	CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO	LYC	Substantially Equivalent	Curasan Ag, Frankfurt Facility	accessdata.fda.gov
March 26, 2004	K040216	CERASORB M ORTHO	MQV	Substantially Equivalent	Curasan AG	accessdata.fda.gov

Compare with other makers

Updated September 17, 2018. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.