Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Jensen Industries, Inc. · Predicate Candidate Screening

17 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

54 daysmedian FDA review time
143 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K183408Jensen Shade Effect LiquidsJensen Industries, Inc.2019-03-201000
K142043INSYNC ZR HIGH TRANSLUCENCY ZIRCONIAJensen Industries, Inc.2014-12-181430
K112806JENSEN ZIRCONIAJensen Industries, Inc.2011-12-01650
K111743THE INSYNC CERAMIC SYSTEMJensen Industries, Inc.2011-09-14850
K070114CREATION CP-ZI PORCELAINJensen Industries, Inc.2007-03-01480
K050838THE LF-P CERAMIC SYSTEMJensen Industries, Inc.2005-05-04330
K043201WILLI GELLER CREATION ZI PORCELAINJensen Industries, Inc.2005-01-11540
K043221WILLI GELLER CREATION CP PORCELAINJensen Industries, Inc.2004-12-20280
K032267R&D DESIGNATION AP-052-5Jensen Industries, Inc.2003-09-17560
K022206JENSEN GOLD FOILJensen Industries, Inc.2002-08-29550
K010414R & D DESIGNATION AP-035Jensen Industries, Inc.2001-03-27430
K010160WILLI GELLER CREAPEARLJensen Industries, Inc.2001-03-27700
K010611R & D DESIGNATION AP-047Jensen Industries, Inc.2001-03-27260
K002904WILLI GELLER CREATION AND LF PORCELAINJensen Industries, Inc.2000-11-06490
K002826EQUITYJensen Industries, Inc.2000-10-24430
K002041WILLI GELLER CREATION & AV PORCELAINJensen Industries, Inc.2000-08-16420
K981490WILLI GELLER CREATION PORCELAINJensen Industries, Inc.1998-10-221780

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda