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
 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
 VENUS Diamond FLOW SYR 1 x 1,8G - HKA2.5 660403572024-10-30
Kulzer GmbH
 VENUS Diamond FLOW SYR 1 x 1,8G - A2 660403552024-10-30
Kulzer GmbH
 VENUS Diamond FLOW SYR 1 x 1,8G - A1 660403542024-10-30
Kulzer GmbH
 VENUS Diamond FLOW SYR ASSORTMENT 660403532024-10-30
Kulzer GmbH
 VENUS DIAMOND PLT REFILL 1x10x0,25G YO 660390302024-10-30
Kulzer GmbH
 VENUS DIAMOND PLT REFILL 1x10x0,25G CO 660390292024-10-30
Kulzer GmbH
 VENUS DIAMOND PLT REFILL 1x10x0,25G AM 660390282024-10-30
Kulzer GmbH
 VENUS DIAMOND PLT REFILL 1x10x0,25G CL 660390272024-10-30
Kulzer GmbH
 VENUS DIAMOND PLT REFILL 1x10x0,25G BXL 660390262024-10-30
Kulzer GmbH
 VENUS DIAMOND PLT REFILL 1x10x0,25G BL 660390252024-10-30
Kulzer GmbH
 VENUS DIAMOND PLT REFILL 1x10x0,25G OB 660390242024-10-30
Kulzer GmbH
 VENUS DIAMOND PLT REFILL 1x10x0,25G D3 660390202024-10-30
Kulzer GmbH
 VENUS DIAMOND PLT REFILL 1x10x0,25G C3 660390192024-10-30
Kulzer GmbH
 VENUS DIAMOND PLT REFILL 2x10x0,25G C2 660390182024-10-30
Kulzer GmbH
 VENUS DIAMOND PLT REFILL 1x10x0,25G B3 660390172024-10-30
Kulzer GmbH
 VENUS DIAMOND PLT REFILL 2x10x0,25G B2 660390162024-10-30
Kulzer GmbH
 VENUS DIAMOND PLT REFILL 2x10x0,25G B1 660390152024-10-30
Kulzer GmbH
 VENUS DIAMOND PLT REFILL 1x10x0,25G HKA5 660390142024-10-30
Kulzer GmbH
 VENUS DIAMOND PLT REFILL 1x10x0,25G A4 660390132024-10-30
Kulzer GmbH
 VENUS DIAMOND PLT REFILL 2x10x0,25G A3,5 660390122024-10-30
Kulzer GmbH
 VENUS DIAMOND PLT REFILL 2x10x0,25G A3 660390112024-10-30
Kulzer GmbH
 VENUS DIAMOND PLT REF.2x10x0,25G HKA2,5 660390102024-10-30
Kulzer GmbH
 VENUS DIAMOND PLT REFILL 2x10x0,25G A2 660390092024-10-30
Kulzer GmbH
 VENUS DIAMOND PLT REFILL 2x10x0,25G A1 660390082024-10-30
Kulzer GmbH
 VENUS DIAMOND SYRINGE REFILL 1x4G YO 660354932024-10-30
Kulzer GmbH
 VENUS DIAMOND SYRINGE REFILL 1x4G CO 660354922024-10-30
Kulzer GmbH
 VENUS DIAMOND SYRINGE REFILL 1x4G AM 660354912024-10-30
Kulzer GmbH
 VENUS DIAMOND SYRINGE REFILL 1x4G CL 660354902024-10-30
Kulzer GmbH
 VENUS DIAMOND SYRINGE REFILL 1x4G OB 660354892024-10-30
Kulzer GmbH
 VENUS DIAMOND SYRINGE REFILL 1x4G BXL 660354882024-10-30
Kulzer GmbH
 VENUS DIAMOND SYRINGE REFILL 1x4G BL 660354872024-10-30
Kulzer GmbH
 VENUS DIAMOND SYRINGE REFILL 1x4G D3 660354832024-10-30
Kulzer GmbH
 VENUS DIAMOND SYRINGE REFILL 1x4G C3 660354822024-10-30
Kulzer GmbH
 VENUS DIAMOND SYRINGE REFILL 1x4G C2 660354812024-10-30
Kulzer GmbH
 VENUS DIAMOND SYRINGE REFILL 1x4G B3 660354802024-10-30
Kulzer GmbH
 VENUS DIAMOND SYRINGE REFILL 1x4G B2 660354792024-10-30
Kulzer GmbH
 VENUS DIAMOND SYRINGE REFILL 1x4G B1 660354782024-10-30
Kulzer GmbH
 VENUS DIAMOND SYRINGE REFILL 1x4G HKA5 660354772024-10-30
Kulzer GmbH
 VENUS DIAMOND SYRINGE REFILL 1x4G A4 660354762024-10-30
Kulzer GmbH
 VENUS DIAMOND SYRINGE REFILL 1x4G A3,5 660354752024-10-30
Kulzer GmbH
 VENUS DIAMOND SYRINGE REFILL 1x4G A3 660354742024-10-30
Kulzer GmbH
 VENUS DIAMOND SYRINGE REFILL 1x4G HKA2,5 660354732024-10-30
Kulzer GmbH
 VENUS DIAMOND SYRINGE REFILL 1x4G A2 660354722024-10-30
Kulzer GmbH
 VENUS DIAMOND SYRINGE REFILL 1x4G A1 660354712024-10-30
Kulzer GmbH
 PALA cre-active, gum, 3 g 660334682024-10-30
Kulzer GmbH
 PALA cre-active, gingiva, light pink, 3 660334662024-10-30
Kulzer GmbH
 PALA cre-active, gingiva, R 50, 3 g 660334652024-10-30
Kulzer GmbH
 PALA cre-active, gingiva, shade 200, 3 g 660334642024-10-30
Kulzer GmbH
 PALA cre-active, gingiva, pink 3 g 660334632024-10-30
Kulzer GmbH
 PALA cre-active, black, 3 g 660334622024-10-30
Kulzer GmbH
 PALA cre-active, maroon, 3 g 660334612024-10-30
Kulzer GmbH
 PALA cre-active, red, 3 g 660334502024-10-30
Kulzer GmbH
 PALA cre-active, pink, 3 g 660334492024-10-30
Kulzer GmbH
 PALA cre-active, polar, 3 g 660334482024-10-30
Kulzer GmbH
 PALA cre-active, white, 3 g 660334472024-10-30
Kulzer GmbH
 PALA cre-active (assortment) 660334452024-10-30
Kulzer GmbH
 ST Basic 8, CE 660303852024-10-30
Kulzer GmbH
 ST Basic 6, CE 660303842024-10-30
Kulzer GmbH
 Mondial 8, B1 / 35L, CE 660173482024-10-30
Kulzer GmbH
 VENUS FLOW SYR 1 x 1,8G - T2 660145752024-10-30
Kulzer GmbH
 VENUS FLOW SYR 1 x 1,8G BASELINER WHITE 660145742024-10-30
Kulzer GmbH
 VENUS FLOW SYR 1 x 1,8G - SB1 660145712024-10-30
Kulzer GmbH
 VENUS FLOW SYR 1 x 1,8G - OA2 660145702024-10-30
Kulzer GmbH
 VENUS FLOW SYR 1 x 1,8G - B3 660145692024-10-30
Kulzer GmbH
 VENUS FLOW SYR 1 x 1,8G - B2 660145682024-10-30
Kulzer GmbH
 VENUS FLOW SYR 1 x 1,8G - A4 660145672024-10-30
Kulzer GmbH
 VENUS FLOW SYR 1 x 1,8G - A3,5 660145662024-10-30
Kulzer GmbH
 VENUS FLOW SYR 1 x 1,8G - A3 660145652024-10-30
Kulzer GmbH
 VENUS FLOW SYR 1 x 1,8G - HKA2,5 660145642024-10-30
Kulzer GmbH
 VENUS FLOW SYR 1 x 1,8G - A2 660145632024-10-30
Kulzer GmbH
 VENUS FLOW SYR 1 x 1,8G - A1 660145622024-10-30
Kulzer GmbH
 SOPIRA CITOJECT PLASTIC SLEEVE 1.8ML 1PC 660054192024-10-30
Kulzer GmbH
 SOPIRA CITOJECT BARR ANG 1.8ML/INCH LA 660023942024-10-30
Kulzer GmbH
 SOPIRA CITOJECT BARR STR 1.8ML/INCH LA 660023932024-10-30
Kulzer GmbH
 SOPIRA CITOJECT SET 1.8ML/INCH FLAT LA 660023922024-10-30
Kulzer GmbH
 CHARISMA SYR 1 x 4G - C3 660000942024-10-30
Kulzer GmbH
 Palabond, 45 ml 647080822024-10-30
Kulzer GmbH
 Palaseal, 2 x 15ml 647080632024-10-30
Kulzer GmbH
 Paladon 65, R 50 veined, 1000 g 647077112024-10-30
Kulzer GmbH
 Paladon 65, clear, 1000 g 647077102024-10-30
Kulzer GmbH
 Paladon 65, pink veined, 1000 g 647077082024-10-30
Kulzer GmbH
 Paladon 65, pink, 1000 g 647077062024-10-30
Kulzer GmbH
 Paladon 65, 500 ml 647076742024-10-30
Kulzer GmbH
 DYNAMIX MIXING TIPS (1 X 50) 600359992024-10-30
Kulzer GmbH
 Basic living Mould Chart A3 507400092024-10-30
Kulzer GmbH
 CK BITE YELLOW ECONOMY 500951942024-10-30
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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