Kulzer L L C

FDA Filings

This page includes the latest FDA filings for Kulzer L L C. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Kulzer L L C holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number3005665377
FEI Number3005665377
NameMarc Henn
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 Address4315 S. Lafayette Blvd
South Bend, IN 46614 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Export Device to the United States But Perform No Other Operation on Device
  • Manufacture Medical Device



Registration Number3005431169
FEI Number3005431169
NameKULZER DENTAL LTD.
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 AddressNO. 1585 GUMEI ROAD
SHANGHAI Shanghai, 200233 CN
Establishment TypeManufacture Medical Device



Registration Number1821514
FEI Number1821514
NameKULZER, LLC
Owner & OperatorKULZER, LLC
Contact Address4315 S. Lafayette Blvd.
South Bend IN 46614 US
Official Correspondent
  • Marc A Henn
  • 1-574-2995444-x
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address4315 S. Lafayette Blvd.
SOUTH BEND, IN 46614 US
Establishment Type
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Complaint File Establishment per 21 CFR 820.198



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 Number3013684905
FEI Number3013684905
NameMarc Henn
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 Address4315 S. Lafayette Blvd
South Bend, IN 46614 US
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



Registration Number3011203516
FEI Number3011203516
NameKulzer SRL
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 AddressCladeria C3 Dietrich Honold 1
Sacalaz-Judet Timis, 307370 RO
Establishment Type
  • Manufacture Medical Device
  • Export Device to the United States But Perform No Other Operation on Device



FDA Filings

Device
Company
DeviceDate
Kulzer, LLC
Venus Bulk Flow ONE2022-04-21
KULZER, LLC
MODERN MATERIALS BASE PLATE WAX2019-11-14
KULZER DENTAL LTD. [KULZER, LLC]
Delara2019-08-16
KULZER, LLC
Venus Rapid Fresh Cleanser2019-07-03
KULZER, LLC
Pala Brillance Denture Cleanser2019-07-03
KULZER, LLC
Surgident Periphery Wax2019-03-27
KULZER, LLC
Orthodontic Tray Wax2019-03-27
KULZER, LLC
Ivory Linguguard2018-02-28
Marc Henn [KULZER, LLC]
Cara i5002017-05-31
Marc Henn [KULZER, LLC]
Cara i5002017-05-31
Marc Henn [KULZER, LLC]
Cara Scan 4.0i2017-05-31
Marc Henn [KULZER, LLC]
Cara Scan 4.0i2017-05-31
Marc Henn [KULZER, LLC]
Cara Scan 4.02017-05-31
Marc Henn [KULZER, LLC]
Cara Scan 4.02017-05-31
Marc Henn [KULZER, LLC]
Cara Scan 4.0 BUNDLE2017-05-31
Marc Henn [KULZER, LLC]
Cara Scan 4.0 BUNDLE2017-05-31
KULZER, LLC
Cara i5002017-05-31
KULZER, LLC
Cara Scan 4.0i2017-05-31
KULZER, LLC
Cara Scan 4.02017-05-31
KULZER, LLC
Cara Scan 4.0 BUNDLE2017-05-31
Marc Henn [KULZER, LLC]
Dima Print Guide2017-05-31
Marc Henn [KULZER, LLC]
Dima Print Ortho2017-05-31
KULZER, LLC
Dima Print Ortho2017-05-31
KULZER GMBH [KULZER, LLC]
Charisma2017-03-17
Kulzer SRL [KULZER, LLC]
Cuttersil Puttly Plus2016-09-07
Kulzer SRL [KULZER, LLC]
Cuttersil Light2016-09-07
Marc Henn [KULZER, LLC]
Kulzer PLT Applicator2016-02-05
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 DENTAL LTD. [KULZER, LLC]
Basic Teeth2014-04-15
Kulzer SRL [KULZER, LLC]
Memoreg, Memoreg 22014-03-25
KULZER GMBH [KULZER, LLC]
iBond Etch 35 Gel2014-03-14
KULZER GMBH [KULZER, LLC]
Gluma Etch 35 Gel2014-03-14
Kulzer SRL [KULZER, LLC]
Palpress Vario2014-02-24
KULZER GMBH [KULZER, LLC]
Palpress Vario2014-02-24
KULZER, LLC
Pala Digital Denture Jaw Gauge2013-12-12
KULZER, LLC
Pala Digital Denture Lip Ruler2013-12-12
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 SRL [KULZER, LLC]
Xantasil2013-09-09
Kulzer SRL [KULZER, LLC]
Cutter Hardener2013-08-12
Kulzer SRL [KULZER, LLC]
Cutter Activator2013-08-12
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 SRL [KULZER, LLC]
Paladon 652013-06-03
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 SRL [KULZER, LLC]
Flexitime2013-05-28
Marc Henn [KULZER, LLC]
Heraceram2013-05-06
Kulzer SRL [KULZER, LLC]
XANTOPREN COMFORT2013-04-11
Kulzer SRL [KULZER, LLC]
PROVIL NOVO2013-04-11
Kulzer SRL [KULZER, LLC]
MEMOSIL2013-04-11
Kulzer SRL [KULZER, LLC]
CUTTERSIL MUCOSA2013-04-11
Kulzer SRL [KULZER, LLC]
FLEXITIME FAST & SCAN LIGHT FLOW2013-04-11
Kulzer SRL [KULZER, LLC]
FLEXITIME MONOPHASE PRO SCAN2013-04-11
Kulzer SRL [KULZER, LLC]
FLEXITME FAST & SCAN MEDIUM FLOW2013-04-11
Kulzer SRL [KULZER, LLC]
FLEXITIME FAST & SCAN PUTTY2013-04-11
Kulzer SRL [KULZER, LLC]
FLEXITIME XTREME 22013-04-11
Kulzer SRL [KULZER, LLC]
FLEXITIME FLOW2013-04-11
Kulzer SRL [KULZER, LLC]
Flexitime Bite2013-04-11
Kulzer SRL [KULZER, LLC]
FLEXITIME MAGNUM 3602013-04-11
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 SRL [KULZER, LLC]
Palaxpress Ultra2013-04-10
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, LLC
Ivory2009-08-31
KULZER, LLC
Ivory Rubber Dam Frame2009-08-31
KULZER, LLC
Gluma Comfort Bond2009-06-15
KULZER GMBH [KULZER, LLC]
Gluma Comfort Bond2009-06-15
Marc Henn [KULZER, LLC]
Venus Supra2007-01-16
Marc Henn [KULZER, LLC]
CITOJECT2006-09-21
Marc Henn [KULZER, LLC]
Heraeceram Zirkonia2006-09-21
Marc Henn [KULZER, LLC]
Translux Wave2006-09-21
Marc Henn [KULZER, LLC]
Translux 2 Wave2006-09-21
Marc Henn [KULZER, LLC]
TRANSLUX POWER BLUE2006-09-21
Marc Henn [KULZER, LLC]
Pala Digital Impression Tray2006-09-20
Marc Henn [KULZER, LLC]
Dima Print Impression Blue2006-09-20
KULZER, LLC
Pala Digital Impression Tray2006-09-20
KULZER, LLC
Dima Print Impression Blue2006-09-20
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 DENTAL LTD. [KULZER, LLC]
BASIC2006-09-11
KULZER DENTAL LTD. [KULZER, LLC]
Artic Digital2006-09-11
KULZER DENTAL LTD. [KULZER, LLC]
ARTIC2006-09-11
Kulzer SRL [KULZER, LLC]
AGFA DENTUS FILM1996-06-11
Kulzer SRL [KULZER, LLC]
Mixing Tips: Green1996-06-11
Kulzer SRL [KULZER, LLC]
Flow Canules1996-06-11
Kulzer SRL [KULZER, LLC]
Flexitime dynamix mixing tips1996-06-11
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
KULZER, LLC
IVORY RUBBER DAM FORCEPS1996-05-13
KULZER, LLC
SURGIDENT COPRWAX1996-05-13
KULZER, LLC
MODERN MATERIALS YELLOW WAX SHEETS1996-05-13
KULZER, LLC
MODERN MATERIALS YELLOW CHECK BITE WAFERS1996-05-13
KULZER, LLC
MODERN MATERIALS UTILITY WAX STRIPS1996-05-13
KULZER, LLC
MODERN MATERIALS SQUARE ROPES1996-05-13
KULZER, LLC
MODERN MATERIALS BITE BLOCKS1996-05-13
KULZER, LLC
Ivory Rubber Dam Starter Kit1996-05-13
KULZER, LLC
Ivory Rubber Dam Complete Kit1996-05-13
KULZER, LLC
IVORY RUBBER DAM CLAMP1996-05-13
KULZER, LLC
DRI CLAVE ORAL EVA1996-05-13
KULZER, LLC
DISPORAL Aspirator Tips1996-05-13
KULZER, LLC
Ivory Rubber Dam Starter Kit1994-05-06
KULZER, LLC
Ivory Rubber Dam Complete Kit1994-05-06
KULZER, LLC
IVORY RUBBER DAM1994-05-06

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2020061123546Shanghai ,China (Mainland) -> Long Beach, CaliforniaARTIFICIAL TEETH7 PKG
2020060448148Shanghai ,China (Mainland) -> Long Beach, CaliforniaARTIFICIAL TEETH7 PKG
2020050711050Shanghai ,China (Mainland) -> Tacoma, WashingtonACRYLIC TEETH26 PKG
2020042254746Shanghai ,China (Mainland) -> Long Beach, CaliforniaARTIFICIAL TEETH27 PKG
2020041642145Shanghai ,China (Mainland) -> Tacoma, WashingtonACRYLIC TEETH26 PKG
202002037348Anvers,Belgium -> Chicago, IllinoisDENTAL PRODUCTS19 PKG
2019021219183Yantian,China (Mainland) -> Long Beach, CaliforniaHOSE ACCESORY KIT554 CTN
2019021219183Yantian,China (Mainland) -> Long Beach, CaliforniaHOSE ACCESORY KIT554 CTN
2018080755341Bremerhaven,Federal Republic of Germany -> Norfolk, VirginiaASPIRATOR TUBES HS 901849902 PCS

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