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Jensen Industries, Inc.

FDA Regulatory Profile

Jensen Industries, Inc. has 0 FDA recalls, 3 inspections, 17 510(k) clearances and 0 compliance actions on record.

Latest inspection
Mar 21, 2017 · VAI
Latest 510(k)
Mar 20, 2019

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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) clearances17Oct 4, 2026Not statedCurrent
Inspections3Oct 26, 2026Not statedCurrent
Compliance actions0Oct 23, 2026Not statedCurrent

Recent FDA Inspections

DateSiteProductClassificationFEI
Mar 21, 2017North Haven, CTDevicesVoluntary Action Indicated (VAI)1219645
May 9, 2013North Haven, CTDevicesVoluntary Action Indicated (VAI)1219645
Sep 3, 2009North Haven, CTDevicesNo Action Indicated (NAI)1219645

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
K183408Jensen Shade Effect LiquidsMar 20, 2019
K142043INSYNC ZR HIGH TRANSLUCENCY ZIRCONIADec 18, 2014
K112806JENSEN ZIRCONIADec 1, 2011
K111743THE INSYNC CERAMIC SYSTEMSep 14, 2011
K070114CREATION CP-ZI PORCELAINMar 1, 2007
K050838THE LF-P CERAMIC SYSTEMMay 4, 2005
K043201WILLI GELLER CREATION ZI PORCELAINJan 11, 2005
K043221WILLI GELLER CREATION CP PORCELAINDec 20, 2004
K032267R&D DESIGNATION AP-052-5Sep 17, 2003
K022206JENSEN GOLD FOILAug 29, 2002
K010414R & D DESIGNATION AP-035Mar 27, 2001
K010160WILLI GELLER CREAPEARLMar 27, 2001
K010611R & D DESIGNATION AP-047Mar 27, 2001
K002904WILLI GELLER CREATION AND LF PORCELAINNov 6, 2000
K002826EQUITYOct 24, 2000
K002041WILLI GELLER CREATION & AV PORCELAINAug 16, 2000
K981490WILLI GELLER CREATION PORCELAINOct 22, 1998

FDA data resources