Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Wieland Dental + Technik GmbH & Co. KG · Predicate Candidate Screening
45 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
53 daysmedian FDA review time
83 days90th percentile
45clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K152118 | Zenostar MT, Zenostar Color Liquids | Wieland Dental + Technik GmbH & Co. KG | 2015-12-16 | 139 | 0 |
| K151142 | IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODEL | Wieland Dental + Technik GmbH & Co. KG | 2015-08-13 | 106 | 0 |
| K142233 | zenostar MO, Zenostar T, Zenostar VisualiZr | Wieland Dental + Technik GmbH & Co. KG | 2015-01-05 | 145 | 1 |
| K130184 | ZENOLUX | Wieland Dental + Technik GmbH & Co. KG | 2013-05-24 | 119 | 0 |
| K112710 | ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR | Wieland Dental + Technik GmbH & Co. KG | 2011-10-17 | 28 | 0 |
| K103773 | ZENOFLEX DIMENSION | Wieland Dental + Technik GmbH & Co. KG | 2011-03-16 | 79 | 0 |
| K103494 | ZENOSTAR MAGIC GLAZE | Wieland Dental + Technik GmbH & Co. KG | 2011-02-16 | 79 | 0 |
| K082257 | ZENO AI ECO DISC | Wieland Dental + Technik GmbH & Co. KG | 2008-09-18 | 41 | 0 |
| K080182 | ZENO PMMA DISC | Wieland Dental + Technik GmbH & Co. KG | 2008-04-08 | 74 | 0 |
| K073108 | ZENO ZR DISC | Wieland Dental + Technik GmbH & Co. KG | 2007-11-21 | 19 | 0 |
| K070772 | PRESSX ZR | Wieland Dental + Technik GmbH & Co. KG | 2007-04-30 | 40 | 0 |
| K051249 | ZIROX | Wieland Dental + Technik GmbH & Co. KG | 2005-07-22 | 67 | 0 |
| K050903 | XAWEX G 100 | Wieland Dental + Technik GmbH & Co. KG | 2005-06-23 | 73 | 0 |
| K050203 | ALLUX | Wieland Dental + Technik GmbH & Co. KG | 2005-02-14 | 17 | 0 |
| K040672 | PORTA REFLEX | Wieland Dental + Technik GmbH & Co. KG | 2004-05-27 | 73 | 0 |
| K040524 | PORTA SOLDER 1090 W | Wieland Dental + Technik GmbH & Co. KG | 2004-05-20 | 80 | 0 |
| K040436 | SIMIDUR SUPERIOR | Wieland Dental + Technik GmbH & Co. KG | 2004-03-05 | 15 | 0 |
| K031326 | IMAGINE REFLEX | Wieland Dental + Technik GmbH & Co. KG | 2003-06-17 | 53 | 0 |
| K031264 | PORTA PRESSOVER | Wieland Dental + Technik GmbH & Co. KG | 2003-06-12 | 52 | 0 |
| K030312 | PORTA IMPLANT | Wieland Dental + Technik GmbH & Co. KG | 2003-03-26 | 55 | 0 |
| K030168 | AGC CEM | Wieland Dental + Technik GmbH & Co. KG | 2003-03-21 | 63 | 0 |
| K023395 | PORTADUR P2 | Wieland Dental + Technik GmbH & Co. KG | 2002-12-11 | 63 | 0 |
| K023391 | BIOPORTA G | Wieland Dental + Technik GmbH & Co. KG | 2002-12-10 | 62 | 0 |
| K023389 | PORTA GEO TI | Wieland Dental + Technik GmbH & Co. KG | 2002-12-06 | 58 | 0 |
| K023392 | AGC SPECIAL ALLOY | Wieland Dental + Technik GmbH & Co. KG | 2002-12-06 | 58 | 0 |
| K022663 | KERADEC | Wieland Dental + Technik GmbH & Co. KG | 2002-10-31 | 83 | 0 |
| K022462 | BIOPORTA SOLDER 1020 | Wieland Dental + Technik GmbH & Co. KG | 2002-09-18 | 54 | 0 |
| K022469 | ECO E4 | Wieland Dental + Technik GmbH & Co. KG | 2002-09-18 | 54 | 0 |
| K022470 | PORTA SOLDER 1080 W | Wieland Dental + Technik GmbH & Co. KG | 2002-09-18 | 54 | 0 |
| K022456 | PORTA IP SOLDER V-1 | Wieland Dental + Technik GmbH & Co. KG | 2002-09-17 | 53 | 0 |
| K022457 | PORTA OPTIMUM SOLDER 710 | Wieland Dental + Technik GmbH & Co. KG | 2002-09-17 | 53 | 0 |
| K022467 | PORTA IP SOLDER V-2 | Wieland Dental + Technik GmbH & Co. KG | 2002-09-17 | 53 | 0 |
| K022468 | PORTA OPTIMUM SOLDER 900 | Wieland Dental + Technik GmbH & Co. KG | 2002-09-17 | 53 | 0 |
| K022454 | PORTA OP SOLDER W-2 | Wieland Dental + Technik GmbH & Co. KG | 2002-09-12 | 48 | 0 |
| K022459 | AUROPAL SOLDER M-1 | Wieland Dental + Technik GmbH & Co. KG | 2002-09-12 | 48 | 0 |
| K022451 | AUROPAL SOLDER W-2 | Wieland Dental + Technik GmbH & Co. KG | 2002-09-11 | 47 | 0 |
| K022452 | PORTA OP SOLDER M-1 | Wieland Dental + Technik GmbH & Co. KG | 2002-09-11 | 47 | 0 |
| K021926 | AUROPAL 60 | Wieland Dental + Technik GmbH & Co. KG | 2002-07-25 | 43 | 0 |
| K021733 | AUTOPAL 50 | Wieland Dental + Technik GmbH & Co. KG | 2002-06-26 | 29 | 0 |
| K020774 | IMAGINE H.E. PRESS DESIGN-CERAMIC | Wieland Dental + Technik GmbH & Co. KG | 2002-05-22 | 72 | 0 |
| K021242 | PORTALLOY 54 | Wieland Dental + Technik GmbH & Co. KG | 2002-05-16 | 27 | 0 |
| K020192 | SIMIDUR S2 | Wieland Dental + Technik GmbH & Co. KG | 2002-03-15 | 52 | 0 |
| K020194 | SIMIDUR KF PLUS | Wieland Dental + Technik GmbH & Co. KG | 2002-03-15 | 52 | 0 |
| K020195 | SIMIDUR S1S | Wieland Dental + Technik GmbH & Co. KG | 2002-03-15 | 52 | 0 |
| K020190 | PORTADUR P 4 | Wieland Dental + Technik GmbH & Co. KG | 2002-03-13 | 50 | 0 |
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