ClearanceBrief
Company ยท US

Denali Corporation

FDA 510(k) clearances and medical device recalls filed under this name, 2007 to 2016. Name variants (Inc, Corp, punctuation) are merged.

9510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
EBFMaterial, Tooth Shade, Resin3
EMACement, Dental3
EBCSealant, Pit And Fissure, And Conditioner1
EIEDam, Rubber1
PMEExternal Cleaning Solution1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Feb 26, 2016K153191Calcium Bridge
Denali Corporation
EBF
Feb 18, 2016K151945Triumph Resin Dam
Denali Corporation
EIE
Dec 16, 2015K152322Resolve 2.0
Denali Corporation
PME
Nov 10, 2014K141503DENALI 501CEMENT
Denali Corporation
EMA
Mar 14, 2014K132393CERCOM II CEMENT
Denali Corporation
EMA
Jan 17, 2008K073101AURAVENEER CEMENT
Denali Corporation
EMA
Jun 5, 2007K071158AURALAY PIT & FISSURE SEALANT
Denali Corporation
EBC
May 10, 2007K070702FUSION RESIN CEMENT AND CORE KIT
Denali Corporation
EBF
May 9, 2007K070693AURAVUE PIT & FISSURE SEALANT
Denali Corporation
EBF

Latest recalls

DateFirm and productCodeLinked 510(k)
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