Jensen Industries, Inc.
North Haven, CT, US
JENSEN INDUSTRIES, INC. appears in FDA device records in North Haven, CT. FDA records list 17 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 17 510(k) clearances for Jensen Industries, Inc. between 1998 and 2019. The busiest year on record is 2000, with 3. The most recent is 2019, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1998 | 1 |
| 2000 | 3 |
| 2001 | 3 |
| 2002 | 1 |
| 2003 | 1 |
| 2004 | 1 |
| 2005 | 2 |
| 2007 | 1 |
| 2011 | 2 |
| 2014 | 1 |
| 2019 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K183408 | Jensen Shade Effect Liquids | EIH | Substantially Equivalent | |
| K142043 | INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA | EIH | Substantially Equivalent | |
| K112806 | JENSEN ZIRCONIA | EIH | Substantially Equivalent | |
| K111743 | THE INSYNC CERAMIC SYSTEM | EIH | Substantially Equivalent | |
| K070114 | CREATION CP-ZI PORCELAIN | EIH | Substantially Equivalent | |
| K050838 | THE LF-P CERAMIC SYSTEM | EIH | Substantially Equivalent | |
| K043201 | WILLI GELLER CREATION ZI PORCELAIN | EIH | Substantially Equivalent | |
| K043221 | WILLI GELLER CREATION CP PORCELAIN | EIH | Substantially Equivalent | |
| K032267 | R&D DESIGNATION AP-052-5 | EJT | Substantially Equivalent | |
| K022206 | JENSEN GOLD FOIL | EJT | Substantially Equivalent | |
| K010611 | R & D DESIGNATION AP-047 | EJT | Substantially Equivalent | |
| K010414 | R & D DESIGNATION AP-035 | EJT | Substantially Equivalent | |
| K010160 | WILLI GELLER CREAPEARL | ELM | Substantially Equivalent | |
| K002904 | WILLI GELLER CREATION AND LF PORCELAIN | EIH | Substantially Equivalent | |
| K002826 | EQUITY | EJT | Substantially Equivalent | |
| K002041 | WILLI GELLER CREATION & AV PORCELAIN | EIH | Substantially Equivalent | |
| K981490 | WILLI GELLER CREATION PORCELAIN | EIH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1219645 | 1219645 | JENSEN INDUSTRIES, INC. | 50 STILLMAN RD., NORTH HAVEN, CT 06473 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain