KXXClass I
Adhesive, Denture, Karaya And Ethylene-oxide Homopolymer
Dental · 21 CFR 872.3450
MDR events8All time
Recalls0All time
Registered firms4Currently listed
510(k) clearances1All time
Recent MDR events
8 adverse event reports on file
- SEA-BOND WAFERSSep 27, 2013InjuryMW5032069
- INTERNAL SCREWDRIVERSep 13, 2006InjuryNewdeal S.a.9615741-2006-00026
- INTERNAL SCREWDRIVERMar 3, 2006MalfunctionNewdeal S.a.9615741-2006-00006
- INTERNAL SCREWDRIVERMay 27, 2005MalfunctionNewdeal S.a.9615741-2005-00019
- INTERNAL SCREWDRIVERMay 25, 2005MalfunctionNewdeal S.a.9615741-2005-00016
- INTERNAL SCREWDRIVERApr 26, 2005MalfunctionNewdeal S.a.9615741-2005-00007
- ATL CAMERA DRAPE (PRODUCT #2950-1153-01)Aug 6, 1998MalfunctionMicrotek Medical1043582-1998-00004
- CUSTOM PAKJul 24, 1998MalfunctionAlcon Laboratories, Inc.1644019-1998-00004
Event type breakdown
Malfunction6
Injury2
Most-reported manufacturers
Product problems
Reported product problem codes, most common first
Device, or device fragments remain in patient3
Replace3
Tip breakage2
Break1
Component(s), broken1
Device, removal of (non-implant)1
Fitting Problem1
Fluid/Blood Leak1
Trend for “Device, or device fragments remain in patient”
No history to chart.
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
4 firms currently registered for this product code
510(k) clearances
1 clearances for this product code