Kulzer G M B H

FDA Filings

This page includes the latest FDA filings for Kulzer 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 Number3006610834
FEI Number3006610834
NameKULZER GMBH
Owner & OperatorKULZER, LLC
Contact Address4315 S. Lafayette Blvd.
South Bend IN 46614 US
Official Correspondent
  • Marc A Henn
  • 1-574-2995444-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressSchlatterstraBe 2
WASSERBURG Bayern, 88142 DE
Establishment TypeManufacture Medical Device

Registration Number9610902
FEI Number3002807166
NameKULZER GMBH
Owner & OperatorKULZER, LLC
Contact Address4315 S. Lafayette Blvd.
South Bend IN 46614 US
Official Correspondent
  • Marc A Henn
  • 1-574-2995444-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration AddressPHILIPP-REIS-STRASSE 8/13
WEHRHEIM Hessen, D-61273 DE
Establishment Type
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device
Company
DeviceDate
Kulzer GmbH
 Signum universal bond 660799272024-11-29
Kulzer GmbH
 Signum universal bond 660799262024-11-29
Kulzer GmbH
 Signum universal bond 660799232024-11-29
Kulzer GmbH
 Signum composite flow 660517132024-11-29
Kulzer GmbH
 Signum composite flow 660503462024-11-29
Kulzer GmbH
 Signum composite flow 660490612024-11-29
Kulzer GmbH
 Signum composite flow 660490602024-11-29
Kulzer GmbH
 Signum composite flow 660490592024-11-29
Kulzer GmbH
 Signum composite flow 660490582024-11-29
Kulzer GmbH
 Signum composite flow 660490572024-11-29
Kulzer GmbH
 Signum composite flow 660490562024-11-29
Kulzer GmbH
 Signum composite flow 660490552024-11-29
Kulzer GmbH
 Signum composite flow 660490542024-11-29
Kulzer GmbH
 Signum composite flow 660490532024-11-29
Kulzer GmbH
 Signum composite flow 660490522024-11-29
Kulzer GmbH
 Signum composite flow 660490512024-11-29
Kulzer GmbH
 Signum composite flow 660489452024-11-29
Kulzer GmbH
 Signum composite flow 660489442024-11-29
Kulzer GmbH
 Signum composite flow 660489432024-11-29
Kulzer GmbH
 Signum composite flow 660489422024-11-29
Kulzer GmbH
 Signum composite flow 660489412024-11-29
Kulzer GmbH
 Signum metal bond 660339162024-11-29
Kulzer GmbH
 Signum metal bond 660339152024-11-29
Kulzer GmbH
 Signum metal bond 660339132024-11-29
Kulzer GmbH
 Signum cre-active 660334462024-11-29
Kulzer GmbH
 Signum matrix 660306702024-11-29
Kulzer GmbH
 Signum matrix 660306692024-11-29
Kulzer GmbH
 Signum cre-active 660200602024-11-29
Kulzer GmbH
 Signum cre-active 660200592024-11-29
Kulzer GmbH
 Signum cre-active 660200582024-11-29
Kulzer GmbH
 Signum cre-active 660200572024-11-29
Kulzer GmbH
 Signum cre-active 660200542024-11-29
Kulzer GmbH
 Signum cre-active 660200532024-11-29
Kulzer GmbH
 Signum cre-active 660200522024-11-29
Kulzer GmbH
 Signum cre-active 660200512024-11-29
Kulzer GmbH
 Signum cre-active 660200502024-11-29
Kulzer GmbH
 Signum cre-active 660200492024-11-29
Kulzer GmbH
 Signum composite 660200362024-11-29
Kulzer GmbH
 Signum composite 660200352024-11-29
Kulzer GmbH
 Signum composite 660200342024-11-29
Kulzer GmbH
 Signum composite 660200302024-11-29
Kulzer GmbH
 Signum composite 660200292024-11-29
Kulzer GmbH
 Signum composite 660200282024-11-29
Kulzer GmbH
 Signum composite 660200272024-11-29
Kulzer GmbH
 Signum composite 660200262024-11-29
Kulzer GmbH
 Signum composite 660200252024-11-29
Kulzer GmbH
 Signum composite 660200242024-11-29
Kulzer GmbH
 Signum composite 660200232024-11-29
Kulzer GmbH
 Signum composite 660200212024-11-29
Kulzer GmbH
 Signum composite 660200202024-11-29
Kulzer GmbH
 Signum composite 660200192024-11-29
Kulzer GmbH
 Signum composite 660200182024-11-29
Kulzer GmbH
 Signum composite 660200172024-11-29
Kulzer GmbH
 Signum composite 660200162024-11-29
Kulzer GmbH
 Signum composite 660200152024-11-29
Kulzer GmbH
 Signum composite 660200142024-11-29
Kulzer GmbH
 Signum composite 660200132024-11-29
Kulzer GmbH
 Signum composite 660200122024-11-29
Kulzer GmbH
 Signum composite 660200112024-11-29
Kulzer GmbH
 Signum composite 660200102024-11-29
Kulzer GmbH
 Signum composite 660200092024-11-29
Kulzer GmbH
 Signum composite 660200082024-11-29
Kulzer GmbH
 Signum composite 660200072024-11-29
Kulzer GmbH
 Signum composite 660200062024-11-29
Kulzer GmbH
 Signum matrix 660197062024-11-29
Kulzer GmbH
 Signum matrix 660197052024-11-29
Kulzer GmbH
 Signum matrix 660197042024-11-29
Kulzer GmbH
 Signum matrix 660197032024-11-29
Kulzer GmbH
 Signum matrix 660197022024-11-29
Kulzer GmbH
 Signum matrix 660197012024-11-29
Kulzer GmbH
 Signum matrix 660197002024-11-29
Kulzer GmbH
 Signum matrix 660196992024-11-29
Kulzer GmbH
 Signum matrix 660196982024-11-29
Kulzer GmbH
 Signum matrix 660196972024-11-29
Kulzer GmbH
 Signum matrix 660196962024-11-29
Kulzer GmbH
 Signum matrix 660196952024-11-29
Kulzer GmbH
 Signum matrix 660196942024-11-29
Kulzer GmbH
 Signum matrix 660196932024-11-29
Kulzer GmbH
 Signum matrix 660196922024-11-29
Kulzer GmbH
 Signum matrix 660196912024-11-29
Kulzer GmbH
 Signum matrix 660196802024-11-29
Kulzer GmbH
 Signum matrix 660196792024-11-29
Kulzer GmbH
 Signum matrix 660196782024-11-29
Kulzer GmbH
 Signum matrix 660196772024-11-29
Kulzer GmbH
 Signum matrix 660196752024-11-29
Kulzer GmbH
 Signum liquid 647141982024-11-29
Kulzer GmbH
 Dima 660874152024-11-07
Kulzer GmbH
 Dima 660816782024-11-07
Kulzer GmbH
 Dima 660816732024-11-07
Kulzer GmbH
 Dima 660816702024-11-07
Kulzer GmbH
 VENUS Diamond FLOW 661003062024-11-01
Kulzer GmbH
 VENUS Diamond FLOW 661002752024-11-01
Kulzer GmbH
 VENUS Diamond FLOW 661002742024-11-01
Kulzer GmbH
 VENUS Diamond FLOW 661002732024-11-01
Kulzer GmbH
 VENUS Diamond FLOW 661002722024-11-01
Kulzer GmbH
 VENUS Diamond FLOW 661002712024-11-01
Kulzer GmbH
 VENUS Diamond FLOW 661002702024-11-01
Kulzer GmbH
 VENUS Diamond FLOW 661002692024-11-01
Kulzer GmbH
 VENUS Diamond FLOW 661002682024-11-01
Kulzer GmbH
 DYNAMIX MIXING TIPS (1 X 50) 400043532024-10-30
KULZER GMBH [KULZER, LLC]
Charisma2017-03-17
KULZER GMBH [KULZER, LLC]
IBond Universal and iBond Ceramic Primer2015-07-08
KULZER GMBH [KULZER, LLC]
IBond Universal and iBond Ceramic Primer2015-07-08
KULZER GMBH [KULZER, LLC]
iBond Etch 35 Gel2014-03-14
KULZER GMBH [KULZER, LLC]
Gluma Etch 35 Gel2014-03-14
KULZER GMBH [KULZER, LLC]
Palpress Vario2014-02-24
KULZER GMBH [KULZER, LLC]
Durafill VS2013-11-12
KULZER GMBH [KULZER, LLC]
Signum Connector2013-10-23
KULZER GMBH [KULZER, LLC]
Signum Insulating Gel2013-10-23
KULZER GMBH [KULZER, LLC]
PALA cre-active2013-10-23
KULZER GMBH [KULZER, LLC]
Premium2013-07-23
KULZER GMBH [KULZER, LLC]
Mondial i DS2013-07-23
KULZER GMBH [KULZER, LLC]
Mondial I2013-07-23
KULZER GMBH [KULZER, LLC]
Palaseal2013-07-11
KULZER GMBH [KULZER, LLC]
Charisma2013-06-17
KULZER GMBH [KULZER, LLC]
Paladon 652013-06-03
KULZER GMBH [KULZER, LLC]
ibond Etch 35 Fluid2013-05-28
KULZER GMBH [KULZER, LLC]
Gluma Etch 35 Fluid2013-05-28
KULZER GMBH [KULZER, LLC]
Gluma Solid Bond2013-04-10
KULZER GMBH [KULZER, LLC]
Gluma Desensitizer2013-04-10
KULZER GMBH [KULZER, LLC]
Palabond2013-04-10
KULZER GMBH [KULZER, LLC]
iBond Self Etch2013-04-10
KULZER GMBH [KULZER, LLC]
Venus Pearl2013-04-10
KULZER GMBH [KULZER, LLC]
Venus Pearl ONE2013-04-10
KULZER GMBH [KULZER, LLC]
Palaxpress Ultra2013-04-10
KULZER GMBH [KULZER, LLC]
Venus Diamond Flow2013-04-10
KULZER GMBH [KULZER, LLC]
Venus Bulk Fill2013-04-10
KULZER GMBH [KULZER, LLC]
Venus Diamond Flow2013-04-10
KULZER GMBH [KULZER, LLC]
Venus Bulk Fill2013-04-10
KULZER GMBH [KULZER, LLC]
iBond Total Etch2013-04-10
KULZER GMBH [KULZER, LLC]
Gluma Comfort Bond + Desensitizer2013-04-10
KULZER GMBH [KULZER, LLC]
iBond Total Etch2013-04-10
KULZER GMBH [KULZER, LLC]
Gluma Comfort Bond + Desensitizer2013-04-10
KULZER GMBH [KULZER, LLC]
Venus Diamond2013-04-10
KULZER GMBH [KULZER, LLC]
Venus Diamond ONE2013-04-10
KULZER GMBH [KULZER, LLC]
Venus2013-04-10
KULZER GMBH [KULZER, LLC]
Charisma ABC2013-04-10
KULZER GMBH [KULZER, LLC]
Gluma Power Gel KNA Sample2011-05-10
KULZER GMBH [KULZER, LLC]
Gluma Desensitizer PowerGel2011-05-10
KULZER GMBH [KULZER, LLC]
GPG KNA Sample2011-05-10
KULZER GMBH [KULZER, LLC]
Gluma Comfort Bond2009-06-15
KULZER GMBH [KULZER, LLC]
VENUS FLOW2006-09-20
KULZER GMBH [KULZER, LLC]
Charisma Flow2006-09-20
KULZER GMBH [KULZER, LLC]
Mondial DS2006-09-15
KULZER GMBH [KULZER, LLC]
MONDIAL2006-09-15
KULZER GMBH [KULZER, LLC]
Mixing Tips: Green1996-06-11
KULZER GMBH [KULZER, LLC]
Flow Canules1996-06-11
KULZER GMBH [KULZER, LLC]
Flexitime dynamix mixing tips1996-06-11

Related Finance Registrations
NCAGE CodeD8789KULZER GMBH
CAGE CodeD8789KULZER GMBH HERAEUS KULZER PROSTHETICS
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020080572690Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaDENTAL PRODUCTS20 PKG
2020072345651Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaDENTAL PRODUCTS HS CODE: 3407000014 PKG
2020071641548Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaDENTAL PRODUCTS HS 3407000020 PKG
2020052747348Bremerhaven,Federal Republic of Germany -> Charleston, South CarolinaDENTAL PRODUCTS CONTAINS DANGEROUS GOODS38 PKG
2020031654694Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina------------ TRHU1933545 DESCRIPTION--------- 12 PACKAGE(S) ON 12 PALLETS DENTAL PRODUCTS CONTAINS DANGEROUS GOODS UN 1993 / CL. 3 / PG. III UN 1247 / CL. 3 / PG. II12 PCS
2020030314304Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina------------ CMAU5799445 DESCRIPTION--------- ON 19 PALLETS + 2 BOXES DENTAL PRODUCTS CONTAINS DANGEROUS GOODS UN 1866 / CL. 3 / PG. II UN 1247 / CL. 3 / PG. II LTD QTY21 PCS
2020022830390Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina------------ APZU4502433 DESCRIPTION--------- ON 18 PALLETS DENTAL PRODUCTS EMERGENCY CONTACT:(001) 352 323 3500 GBK INFO PSN: METHYL METHACRYLATE MONOMER, STABILIZED UN NUMBER: 1247 - IMDG CLASS: 3 - PG: II - FLASHPOINT: 12 C18 PCS
2020020566020Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina------------ CMAU5799445 DESCRIPTION--------- ON 19 PALLETS + 2 BOXES DENTAL PRODUCTS CONTAINS DANGEROUS GOODS UN 1866 / CL. 3 / PG. II UN 1247 / CL. 3 / PG. II LTD QTY21 PCS
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