Not currently registered with FDA under this name
Wieland Dental + Technik GmbH & Co. KG
Pfozheim, Germany. Named as applicant on 45 dental 510(k) clearances between 2002 and 2015. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 452002–2015
- Markets registered in
- 4233 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2000–2026
Registered in 4 markets
Where regulators' registries name Wieland Dental + Technik GmbH & Co. KG as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Wieland Dental + Technik GmbH & Co. KG | 45 clearances | 2002–2015 | Below |
| Canada | Health Canada | Registration holder | WIELAND DENTAL + TECHNIK GMBH & CO. KG | 205 | 2005–2016 | Pure Global AI |
| South Korea | MFDS | Manufacturer | Wieland Dental +Technik GmbH & Co. KGWieland Dental+ Technik GmbH & Co. KG · Wieland Dental + Technik GmbH & Co. KG | 15 | 2002–2011 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | WIELAND DENTAL + TECHNIK GMBH & CO. KG | 13 | 2010–2016 | 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
510(k) clearances
Clearances on which FDA names Wieland Dental + Technik GmbH & Co. KG as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 16 Dec 2015 | K152118 | Zenostar MT, Zenostar Color Liquids | EIH Porcelain Powder |
| 13 Aug 2015 | K151142 | IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID | EBI Rebasing Repairing Relining Denture Resin |
| 5 Jan 2015 | K142233 | zenostar MO, Zenostar T, Zenostar VisualiZr | EIH Porcelain Powder |
| 24 May 2013 | K130184 | ZENOLUX | EIH Porcelain Powder |
| 17 Oct 2011 | K112710 | ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZR | EIH Porcelain Powder |
| 16 Mar 2011 | K103773 | ZENOFLEX DIMENSION | EIH Porcelain Powder |
| 16 Feb 2011 | K103494 | ZENOSTAR MAGIC GLAZE | EIH Porcelain Powder |
| 18 Sep 2008 | K082257 | ZENO AI ECO DISC | EIH Porcelain Powder |
| 8 Apr 2008 | K080182 | ZENO PMMA DISC | EBG Resin Temporary Crown and Bridge |
| 21 Nov 2007 | K073108 | ZENO ZR DISC | EIH Porcelain Powder |
| 30 Apr 2007 | K070772 | PRESSX ZR | EIH Porcelain Powder |
| 22 Jul 2005 | K051249 | ZIROX | EIH Porcelain Powder |
| 23 Jun 2005 | K050903 | XAWEX G 100 | EIH Porcelain Powder |
| 14 Feb 2005 | K050203 | ALLUX | EIH Porcelain Powder |
| 27 May 2004 | K040672 | PORTA REFLEX | EJT Gold-Based Noble Metal Alloy |
| 20 May 2004 | K040524 | PORTA SOLDER 1090 W | EJT Gold-Based Noble Metal Alloy |
| 5 Mar 2004 | K040436 | SIMIDUR SUPERIOR | EJS Alloy Other Noble Metal |
| 17 Jun 2003 | K031326 | IMAGINE REFLEX | EIH Porcelain Powder |
| 12 Jun 2003 | K031264 | PORTA PRESSOVER | EJT Gold-Based Noble Metal Alloy |
| 26 Mar 2003 | K030312 | PORTA IMPLANT | EJT Gold-Based Noble Metal Alloy |
| 21 Mar 2003 | K030168 | AGC CEM | EMA Dental Cement |
| 11 Dec 2002 | K023395 | PORTADUR P2 | EJT Gold-Based Noble Metal Alloy |
| 10 Dec 2002 | K023391 | BIOPORTA G | EJT Gold-Based Noble Metal Alloy |
| 6 Dec 2002 | K023392 | AGC SPECIAL ALLOY | EJT Gold-Based Noble Metal Alloy |
| 6 Dec 2002 | K023389 | PORTA GEO TI | EJT Gold-Based Noble Metal Alloy |
| 31 Oct 2002 | K022663 | KERADEC | EJT Gold-Based Noble Metal Alloy |
| 18 Sep 2002 | K022470 | PORTA SOLDER 1080 W | EJT Gold-Based Noble Metal Alloy |
| 18 Sep 2002 | K022469 | ECO E4 | EJS Alloy Other Noble Metal |
| 18 Sep 2002 | K022462 | BIOPORTA SOLDER 1020 | EJT Gold-Based Noble Metal Alloy |
| 17 Sep 2002 | K022468 | PORTA OPTIMUM SOLDER 900 | EJT Gold-Based Noble Metal Alloy |
| 17 Sep 2002 | K022467 | PORTA IP SOLDER V-2 | EJT Gold-Based Noble Metal Alloy |
| 17 Sep 2002 | K022457 | PORTA OPTIMUM SOLDER 710 | EJT Gold-Based Noble Metal Alloy |
| 17 Sep 2002 | K022456 | PORTA IP SOLDER V-1 | EJT Gold-Based Noble Metal Alloy |
| 12 Sep 2002 | K022459 | AUROPAL SOLDER M-1 | EJT Gold-Based Noble Metal Alloy |
| 12 Sep 2002 | K022454 | PORTA OP SOLDER W-2 | EJT Gold-Based Noble Metal Alloy |
| 11 Sep 2002 | K022452 | PORTA OP SOLDER M-1 | EJT Gold-Based Noble Metal Alloy |
| 11 Sep 2002 | K022451 | AUROPAL SOLDER W-2 | EJT Gold-Based Noble Metal Alloy |
| 25 Jul 2002 | K021926 | AUROPAL 60 | EJT Gold-Based Noble Metal Alloy |
| 26 Jun 2002 | K021733 | AUTOPAL 50 | EJT Gold-Based Noble Metal Alloy |
| 22 May 2002 | K020774 | IMAGINE H.E. PRESS DESIGN-CERAMIC | EIH Porcelain Powder |
| 16 May 2002 | K021242 | PORTALLOY 54 | EJT Gold-Based Noble Metal Alloy |
| 15 Mar 2002 | K020195 | SIMIDUR S1S | EJS Alloy Other Noble Metal |
| 15 Mar 2002 | K020194 | SIMIDUR KF PLUS | EJS Alloy Other Noble Metal |
| 15 Mar 2002 | K020192 | SIMIDUR S2 | EJS Alloy Other Noble Metal |
| 13 Mar 2002 | K020190 | PORTADUR P 4 | EJT Gold-Based Noble Metal Alloy |
Some of these clearances are listed with FDA today by another company: Ivoclar Vivadent, AG (3), Sagemax Bioceramics, Inc. (2), Institut Straumann AG (1).
Sources
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 of the most recent filing, which can be a US agent.