Manufacturer registered with FDA
Jensen Industries, Inc.
North Haven, CT, United States. Lists 6 dental device types with FDA across 1 registered establishment, and holds 17 510(k) clearances as applicant.
- Device types listed
- 6
- Brands and models
- 67
- 510(k) clearances
- 171998–2019
- Markets registered in
- 5118 registrations outside the US
- Establishments
- 1United States
510(k) clearances per year, 1990–2026
Registered in 5 markets
Where regulators' registries name Jensen Industries, Inc. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Jensen Industries, Inc. | 17 clearances | 1998–2019 | Below |
| Canada | Health Canada | Registration holder | JENSEN INDUSTRIES, INCORPORATED | 101 | 2006–2016 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Jensen Industries IncorporatedJensen Industries Incorporated. · JENSEN INDUSTRIES INCORPORATED · +1 | 14 | 1998–1999 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | JENSEN INDUSTRIES INC. | 2 | 2007–2008 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | JENSEN INDUSTRIES INC | 1 | — | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What Jensen Industries, Inc. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Porcelain PowderEIH · Class 2 | Dental ceramics & zirconia | Maker | Imagine Enamel LiquidInSync Ceramic SystemLava EstheticLAVA FrameMiYO 850MiYO Enamel Effect LiquidMiYO Esthetic SystemMiYO Pink | 2011 |
| Resin Temporary Crown and BridgeEBG · Class 2 | Temporary crown & bridge materials | Lister | — | 2014 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Lister | Artex | 2011 |
| Alloy Other Noble MetalEJS · Class 2 | Dental alloys | Maker | AdvantageBlazeCastellIntegrityJ-7JP-5JP-5 w/ AuJWEJWGLandmark ECO 11 morePlatinum Foil 0008Platinum Foil 001Pulse N3SecuritySelectSolutionStabilityStateSuperiorSuperior Plus1400 Solder | 1980 |
| Gold-Based Noble Metal AlloyEJT · Class 2 | Dental alloys | Maker | AztecClassic IVCPS SolderEnduranceEquityFoundationGalileoGold FoilJ-22J-3 27 moreJAJCJCBJCBDJIVJIV-PFJLCBJMCJP-1-AJP-80JP-IJP-IIJPWJRVTJRVT-PFJYELX SolderOvertureP-80 SolderPWS SolderSentrySL-40Spirt SolderVerity585 Solder615 Solder650 Solder | 1994 |
| Porcelain TeethELL · Class 2 | Dental ceramics & zirconia | Lister | — | 2014 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
510(k) clearances
Clearances on which FDA names Jensen Industries, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 20 Mar 2019 | K183408 | Jensen Shade Effect Liquids | EIH Porcelain Powder |
| 18 Dec 2014 | K142043 | INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA | EIH Porcelain Powder |
| 1 Dec 2011 | K112806 | JENSEN ZIRCONIA | EIH Porcelain Powder |
| 14 Sep 2011 | K111743 | THE INSYNC CERAMIC SYSTEM | EIH Porcelain Powder |
| 1 Mar 2007 | K070114 | CREATION CP-ZI PORCELAIN | EIH Porcelain Powder |
| 4 May 2005 | K050838 | THE LF-P CERAMIC SYSTEM | EIH Porcelain Powder |
| 11 Jan 2005 | K043201 | WILLI GELLER CREATION ZI PORCELAIN | EIH Porcelain Powder |
| 20 Dec 2004 | K043221 | WILLI GELLER CREATION CP PORCELAIN | EIH Porcelain Powder |
| 17 Sep 2003 | K032267 | R&D DESIGNATION AP-052-5 | EJT Gold-Based Noble Metal Alloy |
| 29 Aug 2002 | K022206 | JENSEN GOLD FOIL | EJT Gold-Based Noble Metal Alloy |
| 27 Mar 2001 | K010611 | R & D DESIGNATION AP-047 | EJT Gold-Based Noble Metal Alloy |
| 27 Mar 2001 | K010414 | R & D DESIGNATION AP-035 | EJT Gold-Based Noble Metal Alloy |
| 27 Mar 2001 | K010160 | WILLI GELLER CREAPEARL | ELM Teeth Plastic Denture |
| 6 Nov 2000 | K002904 | WILLI GELLER CREATION AND LF PORCELAIN | EIH Porcelain Powder |
| 24 Oct 2000 | K002826 | EQUITY | EJT Gold-Based Noble Metal Alloy |
| 16 Aug 2000 | K002041 | WILLI GELLER CREATION & AV PORCELAIN | EIH Porcelain Powder |
| 22 Oct 1998 | K981490 | WILLI GELLER CREATION PORCELAIN | EIH Porcelain Powder |
Some of these clearances are listed with FDA today by another company: GC America Inc. (7).
Also lists devices cleared under other names
Jensen Industries, Inc. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: 3M Deutschland GmbH (1), Harvest Dental Products, LLC (1), Qinhuangdao Aidite High-Technical Ceramics Co, Ltd. (1), Sagemax Bioceramics, Inc. (1), Espe Dental AG (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 1 Sep 2016 | K161922 | XP202 | 3M Deutschland GmbH | EIH Porcelain Powder |
| 21 May 2014 | K132937 | HARVEST DENTAL POLYMER BLOCKS (ZCAD, AURORA) | Harvest Dental Products, LLC | EBG Resin Temporary Crown and Bridge |
| 20 Jul 2011 | K111291 | AIDITE ZIRCONIA DENTAL CERAMICS | Qinhuangdao Aidite High-Technical Ceramics Co, Ltd. | EIH Porcelain Powder |
| 20 Oct 2006 | K062695 | SAGEMAX Z-BLANK | Sagemax Bioceramics, Inc. | EIH Porcelain Powder |
| 29 Jun 2001 | K011394 | LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM | Espe Dental AG | EIH Porcelain Powder |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| JENSEN INDUSTRIES, INC.FDA reg. 1219645 | NORTH HAVEN, CT, United States | Complaint file establishment, Manufacturer, Repacker / relabeler, Specification developer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 1219645). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.