FDA.reportPublic FDA data

510(k) K033045

Device
DREAM BOND, DREAMCAST CHROME, DREAMCAST V, DREAM FLEXICAST, DREAM LITHECAST
Applicant
American Green Dent. Mfg, Inc.
510(k) number
K033045
Product code
EJH
Decision
Substantially Equivalent (SESE)
Decision date
2003-12-23
Date received
2003-09-29
Regulation
872.3710
Classification name
Alloy, Metal, Base
Medical specialty
Dental
Review panel
Dental
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
N

Applicant Contact#

Contact
ANDREW ROWE
Address
3432 E. 14th St. Los Angeles CA US 90023 90023

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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
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
K021969CHROLOYNeirynck & Vogt NV2002-07-30