Data / Medical devices / United States / Jensen Industries, Inc.

Jensen Industries, Inc.: FDA-registered device maker in North Haven, CT, United States, 7 510(k) clearances

Name: Jensen Industries, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Jensen Industries, Inc. is registered with the FDA (registration 1219645) in North Haven, CT, United States. It lists 6 device types. The FDA files 7 510(k) clearances under its listings, the newest dated March 20, 2019. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1219645
Address: 50 Stillman RD., North Haven, CT, United States, 06473
Owner or operator: JENSEN INDUSTRIES, INC. (1219645)
Roles: Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
First device listed: June 25, 1980
Registered through: 2026
Brand names listed: 1400 Solder, 585 Solder, 615 Solder, 650 Solder, Advantage, Artex, Aztec, Blaze and more

Devices it lists

Device	Product code	Class	Role	Source
Alloy, Gold-Based Noble Metal	EJT	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Alloy, Other Noble Metal	EJS	2	Complaint file establishment, Manufacturer	accessdata.fda.gov
Articulators	EJP	1	Complaint file establishment	accessdata.fda.gov
Crown And Bridge, Temporary, Resin	EBG	2	Repackager or relabeler	accessdata.fda.gov
Powder, Porcelain	EIH	2	Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Teeth, Porcelain	ELL	2	Repackager or relabeler	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
March 20, 2019	K183408	Jensen Shade Effect Liquids	EIH	Substantially Equivalent	Jensen Industries, Inc.	accessdata.fda.gov
September 1, 2016	K161922	XP202	EIH	Substantially Equivalent	3M Deutschland GmbH	accessdata.fda.gov
May 21, 2014	K132937	HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA)	EBG	Substantially Equivalent	Harvest Dental Products, LLC	accessdata.fda.gov
September 14, 2011	K111743	THE INSYNC CERAMIC SYSTEM	EIH	Substantially Equivalent	Jensen Industries, Inc.	accessdata.fda.gov
July 20, 2011	K111291	AIDITE ZIRCONIA DENTAL CERAMICS	EIH	Substantially Equivalent	Qinhuangdao Aidite High-Technical Ceramics Co, Ltd.	accessdata.fda.gov
October 20, 2006	K062695	SAGEMAX Z-BLANK	EIH	Substantially Equivalent	Sagemax Bioceramics, Inc.	accessdata.fda.gov
June 29, 2001	K011394	LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM	EIH	Substantially Equivalent	Espe Dental AG	accessdata.fda.gov

Compare with other makers

Updated March 20, 2019. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.