Atlas FDA

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-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K152118Zenostar MT, Zenostar Color LiquidsWieland Dental + Technik GmbH & Co. KG2015-12-161390
K151142IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELWieland Dental + Technik GmbH & Co. KG2015-08-131060
K142233zenostar MO, Zenostar T, Zenostar VisualiZrWieland Dental + Technik GmbH & Co. KG2015-01-051451
K130184ZENOLUXWieland Dental + Technik GmbH & Co. KG2013-05-241190
K112710ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZRWieland Dental + Technik GmbH & Co. KG2011-10-17280
K103773ZENOFLEX DIMENSIONWieland Dental + Technik GmbH & Co. KG2011-03-16790
K103494ZENOSTAR MAGIC GLAZEWieland Dental + Technik GmbH & Co. KG2011-02-16790
K082257ZENO AI ECO DISCWieland Dental + Technik GmbH & Co. KG2008-09-18410
K080182ZENO PMMA DISCWieland Dental + Technik GmbH & Co. KG2008-04-08740
K073108ZENO ZR DISCWieland Dental + Technik GmbH & Co. KG2007-11-21190
K070772PRESSX ZRWieland Dental + Technik GmbH & Co. KG2007-04-30400
K051249ZIROXWieland Dental + Technik GmbH & Co. KG2005-07-22670
K050903XAWEX G 100Wieland Dental + Technik GmbH & Co. KG2005-06-23730
K050203ALLUXWieland Dental + Technik GmbH & Co. KG2005-02-14170
K040672PORTA REFLEXWieland Dental + Technik GmbH & Co. KG2004-05-27730
K040524PORTA SOLDER 1090 WWieland Dental + Technik GmbH & Co. KG2004-05-20800
K040436SIMIDUR SUPERIORWieland Dental + Technik GmbH & Co. KG2004-03-05150
K031326IMAGINE REFLEXWieland Dental + Technik GmbH & Co. KG2003-06-17530
K031264PORTA PRESSOVERWieland Dental + Technik GmbH & Co. KG2003-06-12520
K030312PORTA IMPLANTWieland Dental + Technik GmbH & Co. KG2003-03-26550
K030168AGC CEMWieland Dental + Technik GmbH & Co. KG2003-03-21630
K023395PORTADUR P2Wieland Dental + Technik GmbH & Co. KG2002-12-11630
K023391BIOPORTA GWieland Dental + Technik GmbH & Co. KG2002-12-10620
K023389PORTA GEO TIWieland Dental + Technik GmbH & Co. KG2002-12-06580
K023392AGC SPECIAL ALLOYWieland Dental + Technik GmbH & Co. KG2002-12-06580
K022663KERADECWieland Dental + Technik GmbH & Co. KG2002-10-31830
K022462BIOPORTA SOLDER 1020Wieland Dental + Technik GmbH & Co. KG2002-09-18540
K022469ECO E4Wieland Dental + Technik GmbH & Co. KG2002-09-18540
K022470PORTA SOLDER 1080 WWieland Dental + Technik GmbH & Co. KG2002-09-18540
K022456PORTA IP SOLDER V-1Wieland Dental + Technik GmbH & Co. KG2002-09-17530
K022457PORTA OPTIMUM SOLDER 710Wieland Dental + Technik GmbH & Co. KG2002-09-17530
K022467PORTA IP SOLDER V-2Wieland Dental + Technik GmbH & Co. KG2002-09-17530
K022468PORTA OPTIMUM SOLDER 900Wieland Dental + Technik GmbH & Co. KG2002-09-17530
K022454PORTA OP SOLDER W-2Wieland Dental + Technik GmbH & Co. KG2002-09-12480
K022459AUROPAL SOLDER M-1Wieland Dental + Technik GmbH & Co. KG2002-09-12480
K022451AUROPAL SOLDER W-2Wieland Dental + Technik GmbH & Co. KG2002-09-11470
K022452PORTA OP SOLDER M-1Wieland Dental + Technik GmbH & Co. KG2002-09-11470
K021926AUROPAL 60Wieland Dental + Technik GmbH & Co. KG2002-07-25430
K021733AUTOPAL 50Wieland Dental + Technik GmbH & Co. KG2002-06-26290
K020774IMAGINE H.E. PRESS DESIGN-CERAMICWieland Dental + Technik GmbH & Co. KG2002-05-22720
K021242PORTALLOY 54Wieland Dental + Technik GmbH & Co. KG2002-05-16270
K020192SIMIDUR S2Wieland Dental + Technik GmbH & Co. KG2002-03-15520
K020194SIMIDUR KF PLUSWieland Dental + Technik GmbH & Co. KG2002-03-15520
K020195SIMIDUR S1SWieland Dental + Technik GmbH & Co. KG2002-03-15520
K020190PORTADUR P 4Wieland Dental + Technik GmbH & Co. KG2002-03-13500

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