Thommen Medical AG

FDA Regulatory Profile

Summary

Total Recalls
2
510(k) Clearances
26
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1322-2024Class IIimpression coping, repositionable, short, screw-retained, PF 4.0January 24, 2024
Z-1390-2019Class IIAdapter for handpiece, guided, reusable, for guide sleeve 0 4.8 mm Article number: 3.04.090 - ProdApril 3, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K171795Thommen Implant SystemSeptember 29, 2017
K160244VARIOuniteJune 2, 2016
K151984Thommen Milling Abutment for CAD/CAMMarch 10, 2016
K121334VARIOECOAugust 14, 2012
K111984SPI VARIO ANGLED ABUTMENTNovember 10, 2011
K102804SPI TITANIUM BASE FOR CAD/CAMApril 20, 2011
K101798SPI VARIOMULTI ANGLED ABUTMENTAugust 19, 2010
K093615SPI DENTAL IMPLANT, ELEMENTMarch 4, 2010
K092248SPI CUSTOMIZABLE GINGIVA FORMERSeptember 25, 2009
K090154SPI DENTAL IMPLANT INICELLJuly 27, 2009
K090153SPI VARIOMULTI ANGLED ABUTMENTMarch 27, 2009
K072856SPI VARIOMULTI ABUTMENTFebruary 15, 2008
K072649SPI SYSTEM DENTAL IMPLANTSDecember 6, 2007
K073141SPI ART ABUTMENTDecember 5, 2007
K072933SPI CONTACT PLATFORM O 4.0 MMNovember 15, 2007
K071453SPI EASY 4.0 ABUTMENTSeptember 19, 2007
K070290SPI VECTODRILL CERAMIC DRILLSApril 17, 2007
K070007SPI ELEMENT PLATFORM O 4.0 MMJanuary 10, 2007
K061807SPI ART ABUTMENTSJuly 31, 2006
K051527SPI EASY TEMPORARY CAPJuly 28, 2005