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510(k) K001798

Device
DC TITAN
Applicant
AUSTENAL, INC.
510(k) number
K001798
Product code
EJH  
Decision
Substantially Equivalent (SESE)
Decision date
2000-07-31
Date received
2000-06-14
Regulation
872.3710
Classification name
Alloy, Metal, Base
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
RONALD DUDEK
Address
4101 W. 51st St. Chicago IL US 60632 60632

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code EJH  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K123929BEGOPAL+Bego Bremer Goldschlaegerei Wilh. Herbst GmbH & CO2013-03-14
K040180CONTINUM VAalba Dent, Inc.2004-03-04
K040179CONTINUMAalba Dent, Inc.2004-03-03
K033356VERASOFT ESAalba Dent, Inc.2003-12-30
K033045DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECASTAmerican Green Dent. Mfg, Inc.2003-12-23
K032136WIROBOND CBego U.S.A.2003-09-04
K031627NANO-TICROWNNano-Write Corp.2003-06-11
K030632PD CASTA-HMountain Medico, Inc.2003-05-07
K030416CERACAST-VMountain Medico, Inc.2003-04-14
K030161SUPERBONDAmerican Dent-All, Inc.2003-03-17
K024214KAVO EVEREST TITANBLANKKavo America2003-03-12
K023499GOLD CORE PLUSPentron Laboratory Technologies2003-01-13
K023502JEWEL CAST PLUSPentron Laboratory Technologies2002-12-18
K023477BIOLOYNeirynck & Vogt NV2002-12-13
K021971CERALOYNeirynck & Vogt NV2002-08-01

Legacy Summary#

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FDA Review#

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