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Curasan AG

FDA Regulatory Profile

Curasan AG has 0 FDA recalls, 3 inspections, 10 510(k) clearances and 0 compliance actions on record.

Latest inspection
May 12, 2017 · NAI
Latest 510(k)
Sep 17, 2018

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls0Oct 23, 2026Not statedCurrent
510(k) clearances10Oct 4, 2026Not statedCurrent
Inspections3Oct 25, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
May 12, 2017Kleinostheim, GermanyDevicesNo Action Indicated (NAI)3003771570
Mar 9, 2015Wake Forest, NCBiologicsVoluntary Action Indicated (VAI)3007346541
Jan 8, 2014Wake Forest, NCBiologicsNo Action Indicated (NAI)3007346541

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

Recent 510(k) Clearances

K-NumberDeviceDate
K181721Ceracell Ortho FoamSep 17, 2018
K160566Cerasorb Ortho FoamDec 2, 2016
K111105CURASAN OSSEOLIVE DENTALDec 20, 2012
K103709CERACELL DENTALMar 10, 2011
K102872OSBONE DENTALJan 12, 2011
K100841BONEOPTIMIZERAug 19, 2010
K063106REVOIS IMPLANT SYSTEMJun 11, 2007
K040216CERASORB M ORTHOMar 26, 2004
K031651MODIFICATION TO CERASORB ORTHOAug 13, 2003
K014156CERASORB ORTHOMar 18, 2002

FDA data resources