Deltamed G M B H

FDA Filings

This page includes the latest FDA filings for Deltamed G M B H. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3002789526
FEI Number3002789526
NameMICHAELO'MALLEY
Owner & OperatorDELTAMED GMBH
Contact AddressRAIFFEISENSTR. 16 --
FRIEDBERG DE-NOTA 61169 DE
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address401 NORTH MICHIGAN AVE. SUITE 2500
CHICAGO, IL 60611 US
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
DeltaMed GmbH
Insure® UNIVERSAL AutoMix 625AMU2024-09-02
DeltaMed GmbH
Insure® UNIVERSAL AutoMix 625AML2024-09-02
DeltaMed GmbH
Insure® UNIVERSAL AutoMix 625AMC2024-09-02
DeltaMed GmbH
Insure® UNIVERSAL 6251072024-09-02
DeltaMed GmbH
Insure® UNIVERSAL 6251062024-09-02
DeltaMed GmbH
Insure® UNIVERSAL 6251052024-09-02
DeltaMed GmbH
Insure® UNIVERSAL 6251042024-09-02
DeltaMed GmbH
Insure® UNIVERSAL 6251032024-09-02
DeltaMed GmbH
Insure® UNIVERSAL 6251022024-09-02
DeltaMed GmbH
Insure® UNIVERSAL 6251012024-09-02
DeltaMed GmbH
Renamel® Microfill 6073OP2024-08-09
DeltaMed GmbH
3Delta Etemp 16110302023-09-25
DeltaMed GmbH
3Delta Etemp 16110202023-09-25
DeltaMed GmbH
3Delta Etemp 16110102023-09-25
DeltaMed GmbH
Renamel® Microfill 6071OP2023-09-22
DeltaMed GmbH
Renamel® Flowable Microfill 3011OP2023-09-22
DeltaMed GmbH
DELTAGLACE 13700302023-07-07
DeltaMed GmbH
DELTABOND 13700202023-07-07
DeltaMed GmbH
DELTASPLINT 13700102023-07-07
DeltaMed GmbH
Enamelize™ 9061012023-06-20
DeltaMed GmbH
Enamelize™ 9060002023-06-20
DeltaMed GmbH
Brush & Sculpt™ 6271012023-06-20
DeltaMed GmbH
Insure® Lite Automix 605ACL2023-06-20
DeltaMed GmbH
Insure® Lite 6051082023-06-20
DeltaMed GmbH
Insure® Lite 6051072023-06-20
DeltaMed GmbH
Insure® Lite 6051062023-06-20
DeltaMed GmbH
Insure® Lite 6051052023-06-20
DeltaMed GmbH
Insure® Lite 6051042023-06-20
DeltaMed GmbH
Insure® Lite 6051032023-06-20
DeltaMed GmbH
Insure® Lite 6051022023-06-20
DeltaMed GmbH
Prevue® 6041072023-06-20
DeltaMed GmbH
Prevue® 6041062023-06-20
DeltaMed GmbH
Prevue® 6041052023-06-20
DeltaMed GmbH
Prevue® 6041042023-06-20
DeltaMed GmbH
Prevue® 6041032023-06-20
DeltaMed GmbH
Prevue® 6041022023-06-20
DeltaMed GmbH
Prevue® 6041012023-06-20
DeltaMed GmbH
Creative Color® Opaquer 603A352023-06-20
DeltaMed GmbH
Creative Color® Opaquer 6031WO2023-06-20
DeltaMed GmbH
Creative Color® Pink Opaque™ 6031PO2023-06-20
DeltaMed GmbH
Creative Color® Tint 6031LB2023-06-20
DeltaMed GmbH
Creative Color® Tint 6031HY2023-06-20
DeltaMed GmbH
Creative Color® Tint 6031DB2023-06-20
DeltaMed GmbH
Creative Color® Opaquer 6031D32023-06-20
DeltaMed GmbH
Creative Color® Opaquer 6031C42023-06-20
DeltaMed GmbH
Creative Color® Opaquer 6031C22023-06-20
DeltaMed GmbH
Creative Color® Opaquer 6031C12023-06-20
DeltaMed GmbH
Creative Color® Opaquer 6031B32023-06-20
DeltaMed GmbH
Creative Color® Opaquer 6031B22023-06-20
DeltaMed GmbH
Creative Color® Opaquer 6031B02023-06-20
DeltaMed GmbH
Creative Color® Opaquer 6031A42023-06-20
DeltaMed GmbH
Creative Color® Opaquer 6031A32023-06-20
DeltaMed GmbH
Creative Color® Opaquer 6031A22023-06-20
DeltaMed GmbH
Creative Color® Opaquer 6031A12023-06-20
DeltaMed GmbH
Creative Color® Clear Liquid Resin 6031142023-06-20
DeltaMed GmbH
Creative Color® Tint 60310V2023-06-20
DeltaMed GmbH
Creative Color® Tint 60310G2023-06-20
DeltaMed GmbH
Insure® Silanator 6021162023-06-20
DeltaMed GmbH
Renamel® De-Mark™ 7011DM2023-06-13
DeltaMed GmbH
CosmeCore™ 6227A22023-06-13
DeltaMed GmbH
CosmeCore™ 62270W2023-06-13
DeltaMed GmbH
CosmeCore™ 62270B2023-06-13
DeltaMed GmbH
CosmeCore™ 6221A22023-06-13
DeltaMed GmbH
CosmeCore™ 62210W2023-06-13
DeltaMed GmbH
CosmeCore™ 62210B2023-06-13
DeltaMed GmbH
COSMESEAL™ Filled 61710W2023-06-13
DeltaMed GmbH
COSMESEAL™ Clear 6170CL2023-06-13
DeltaMed GmbH
Renamel® Microfill 6151BO2023-06-13
DeltaMed GmbH
Insure® Lite 6051012023-06-13
DeltaMed GmbH
Insure® 6021082023-06-13
DeltaMed GmbH
Insure® 6021072023-06-13
DeltaMed GmbH
Insure® 6021062023-06-13
DeltaMed GmbH
Insure® 6021052023-06-13
DeltaMed GmbH
Insure® 6021042023-06-13
DeltaMed GmbH
Insure® 6021032023-06-13
DeltaMed GmbH
Insure® 6021022023-06-13
DeltaMed GmbH
Insure® 6021012023-06-13
DeltaMed GmbH
Renamel® Flowable Microfill 3011MI2023-06-08
DeltaMed GmbH
Renamel® Flowable Microfill 3011LO2023-06-08
DeltaMed GmbH
Renamel® Flowable Microfill 3011LI2023-06-08
DeltaMed GmbH
Renamel® Flowable Microfill 3011DI2023-06-08
DeltaMed GmbH
Renamel® Flowable Microfill 3011D42023-06-08
DeltaMed GmbH
Renamel® Flowable Microfill 3011D32023-06-08
DeltaMed GmbH
Renamel® Flowable Microfill 3011D22023-06-08
DeltaMed GmbH
Renamel® Flowable Microfill 3011C52023-06-08
DeltaMed GmbH
Renamel® Flowable Microfill 3011C42023-06-08
DeltaMed GmbH
Renamel® Flowable Microfill 3011C32023-06-08
DeltaMed GmbH
Renamel® Flowable Microfill 3011C22023-06-08
DeltaMed GmbH
Renamel® Flowable Microfill 3011C12023-06-08
DeltaMed GmbH
Renamel® Flowable Microfill 3011B42023-06-08
DeltaMed GmbH
Renamel® Flowable Microfill 3011B32023-06-08
DeltaMed GmbH
Renamel® Flowable Microfill 3011B22023-06-08
DeltaMed GmbH
Renamel® Flowable Microfill 3011B12023-06-08
DeltaMed GmbH
Renamel® Flowable Microfill 3011A62023-06-08
DeltaMed GmbH
Renamel® Flowable Microfill 3011A52023-06-08
DeltaMed GmbH
Renamel® Flowable Microfill 3011A42023-06-08
DeltaMed GmbH
Renamel® Flowable Microfill 3011A32023-06-08
DeltaMed GmbH
Renamel® Flowable Microfill 3011A22023-06-08
DeltaMed GmbH
Renamel® Flowable Microfill 3011A12023-06-08
DeltaMed GmbH
Renamel® Flowable Microfill 30110W2023-06-08
DeltaMed GmbH
3Delta Denture Base - 3Delta Denture Bond - 3Delta Denture Fix2022-01-10
DeltaMed GmbH
3Delta Crown2021-12-06
DeltaMed GmbH
P Pro Crown & Bridge2020-07-31
MICHAELO'MALLEY [DELTAMED GMBH]
P pro Splint2020-01-23
MICHAELO'MALLEY [DELTAMED GMBH]
3Delta Splint2020-01-23
MICHAELO'MALLEY [DELTAMED GMBH]
Renamel Microfill2019-05-02
MICHAELO'MALLEY [DELTAMED GMBH]
NANO +Plus2019-05-02
MICHAELO'MALLEY [DELTAMED GMBH]
RS Surgical Guide2018-12-18
MICHAELO'MALLEY [DELTAMED GMBH]
P Pro Surgical Guide Clear2018-12-18
MICHAELO'MALLEY [DELTAMED GMBH]
3 Delta Surgical Guide2018-12-18
MICHAELO'MALLEY [DELTAMED GMBH]
RS Try-In2018-12-18
MICHAELO'MALLEY [DELTAMED GMBH]
P pro Try-In2018-12-18
MICHAELO'MALLEY [DELTAMED GMBH]
3 Delta Try In2018-12-18
MICHAELO'MALLEY [DELTAMED GMBH]
RS Impression Tray2018-12-18
MICHAELO'MALLEY [DELTAMED GMBH]
P pro Impression Tray Green2018-12-18
MICHAELO'MALLEY [DELTAMED GMBH]
3 Delta Tray2018-12-18
MICHAELO'MALLEY [DELTAMED GMBH]
e-Dent Temp2011-11-22
DELTAMED GMBH
EXTRA-ORAL, ADDITIVE COMPUTER AIDED MANUFACTURE AND CURING SYSTEM2011-02-18
MICHAELO'MALLEY [DELTAMED GMBH]
Brush & Sculpt2009-12-01
MICHAELO'MALLEY [DELTAMED GMBH]
RSVP Light Body2008-04-03
MICHAELO'MALLEY [DELTAMED GMBH]
RSVP Heavy Body2008-04-03
MICHAELO'MALLEY [DELTAMED GMBH]
Renamel Flowable Microhybrid2008-04-03
MICHAELO'MALLEY [DELTAMED GMBH]
Renamel Flowable Microfill2008-04-03
MICHAELO'MALLEY [DELTAMED GMBH]
Renamel Microhybrid2008-04-03
MICHAELO'MALLEY [DELTAMED GMBH]
Prevue2008-04-03
MICHAELO'MALLEY [DELTAMED GMBH]
Insure Kit2008-04-03
MICHAELO'MALLEY [DELTAMED GMBH]
Enamelize2008-04-03
MICHAELO'MALLEY [DELTAMED GMBH]
Gingafill2008-04-03
MICHAELO'MALLEY [DELTAMED GMBH]
Renamel NANO2008-04-03
MICHAELO'MALLEY [DELTAMED GMBH]
CosmeSeal2008-04-03
MICHAELO'MALLEY [DELTAMED GMBH]
CosmeCore2008-04-03
MICHAELO'MALLEY [DELTAMED GMBH]
GingaGuard2008-04-03

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