510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Wieland Dental + Technik GmbH & Co. KG

Pforzheim, DE

Wieland Dental + Technik GmbH & Co. KG appears in FDA device records in Pforzheim, DE. FDA records list 45 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
45
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 45 510(k) clearances for Wieland Dental + Technik GmbH & Co. KG between 2002 and 2015. The busiest year on record is 2002, with 24. The most recent is 2015, with 3.

Clearances by year, as a table
510(k) clearance decisions for Wieland Dental + Technik GmbH & Co. KG, by decision year
YearClearances
200224
20034
20043
20053
20072
20082
20113
20131
20153
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K152118Zenostar MT, Zenostar Color LiquidsEIHSubstantially Equivalent
K151142IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUIDEBISubstantially Equivalent
K142233zenostar MO, Zenostar T, Zenostar VisualiZrEIHSubstantially Equivalent
K130184ZENOLUXEIHSubstantially Equivalent
K112710ZENOTEC ZR BRIDGE, ZENOSTAR ZR TRANSLUCENT, ZENOTEC COLOR ZR, ZENOSTAR COLOR ZREIHSubstantially Equivalent
K103773ZENOFLEX DIMENSIONEIHSubstantially Equivalent
K103494ZENOSTAR MAGIC GLAZEEIHSubstantially Equivalent
K082257ZENO AI ECO DISCEIHSubstantially Equivalent
K080182ZENO PMMA DISCEBGSubstantially Equivalent
K073108ZENO ZR DISCEIHSubstantially Equivalent
K070772PRESSX ZREIHSubstantially Equivalent
K051249ZIROXEIHSubstantially Equivalent
K050903XAWEX G 100EIHSubstantially Equivalent
K050203ALLUXEIHSubstantially Equivalent
K040672PORTA REFLEXEJTSubstantially Equivalent
K040524PORTA SOLDER 1090 WEJTSubstantially Equivalent
K040436SIMIDUR SUPERIOREJSSubstantially Equivalent
K031326IMAGINE REFLEXEIHSubstantially Equivalent
K031264PORTA PRESSOVEREJTSubstantially Equivalent
K030312PORTA IMPLANTEJTSubstantially Equivalent
K030168AGC CEMEMASubstantially Equivalent
K023395PORTADUR P2EJTSubstantially Equivalent
K023391BIOPORTA GEJTSubstantially Equivalent
K023392AGC SPECIAL ALLOYEJTSubstantially Equivalent
K023389PORTA GEO TIEJTSubstantially Equivalent
K022663KERADECEJTSubstantially Equivalent
K022470PORTA SOLDER 1080 WEJTSubstantially Equivalent
K022469ECO E4EJSSubstantially Equivalent
K022462BIOPORTA SOLDER 1020EJTSubstantially Equivalent
K022468PORTA OPTIMUM SOLDER 900EJTSubstantially Equivalent
K022467PORTA IP SOLDER V-2EJTSubstantially Equivalent
K022457PORTA OPTIMUM SOLDER 710EJTSubstantially Equivalent
K022456PORTA IP SOLDER V-1EJTSubstantially Equivalent
K022459AUROPAL SOLDER M-1EJTSubstantially Equivalent
K022454PORTA OP SOLDER W-2EJTSubstantially Equivalent
K022452PORTA OP SOLDER M-1EJTSubstantially Equivalent
K022451AUROPAL SOLDER W-2EJTSubstantially Equivalent
K021926AUROPAL 60EJTSubstantially Equivalent
K021733AUTOPAL 50EJTSubstantially Equivalent
K020774IMAGINE H.E. PRESS DESIGN-CERAMICEIHSubstantially Equivalent
K021242PORTALLOY 54EJTSubstantially Equivalent
K020195SIMIDUR S1SEJSSubstantially Equivalent
K020194SIMIDUR KF PLUSEJSSubstantially Equivalent
K020192SIMIDUR S2EJSSubstantially Equivalent
K020190PORTADUR P 4EJTSubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

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