Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Curasan AG — Predicate Candidate Screening

10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

104 daysmedian FDA review time

610 days90th percentile

10clearances measured

K-number	Device	Applicant	Decided	Review days
K181721	Ceracell Ortho Foam	Curasan AG	2018-09-17	80
K160566	Cerasorb Ortho Foam	Curasan AG	2016-12-02	277
K111105	CURASAN OSSEOLIVE DENTAL	Curasan AG	2012-12-20	610
K103709	CERACELL DENTAL	Curasan AG	2011-03-10	80
K102872	OSBONE DENTAL	Curasan AG	2011-01-12	104
K100841	BONEOPTIMIZER	Curasan AG	2010-08-19	147
K063106	REVOIS IMPLANT SYSTEM	Curasan AG	2007-06-11	243
K040216	CERASORB M ORTHO	Curasan AG	2004-03-26	56
K031651	MODIFICATION TO CERASORB ORTHO	Curasan AG	2003-08-13	77
K014156	CERASORB ORTHO	Curasan AG	2002-03-18	89

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda