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.
Registration Number | 3006610834 |
FEI Number | 3006610834 |
Name | KULZER GMBH |
Owner & Operator | KULZER, LLC |
Contact Address | 4315 S. Lafayette Blvd. South Bend IN 46614 US |
Official Correspondent |
|
US Agent |
|
Registration Status | 1 |
Initial Importer | N |
Registration Expiration | 2020-04-25 |
Registration Address | SchlatterstraBe 2 WASSERBURG Bayern, 88142 DE |
Establishment Type | Manufacture Medical Device |
Registration Number | 9610902 |
FEI Number | 3002807166 |
Name | KULZER GMBH |
Owner & Operator | KULZER, LLC |
Contact Address | 4315 S. Lafayette Blvd. South Bend IN 46614 US |
Official Correspondent |
|
US Agent |
|
Registration Status | 1 |
Initial Importer | N |
Registration Expiration | 2020-04-25 |
Registration Address | PHILIPP-REIS-STRASSE 8/13 WEHRHEIM Hessen, D-61273 DE |
Establishment Type |
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Device Company | Device | Date |
---|---|---|
KULZER GMBH [KULZER, LLC] | Charisma | 2017-03-17 |
KULZER GMBH [KULZER, LLC] | IBond Universal and iBond Ceramic Primer | 2015-07-08 |
KULZER GMBH [KULZER, LLC] | IBond Universal and iBond Ceramic Primer | 2015-07-08 |
KULZER GMBH [KULZER, LLC] | iBond Etch 35 Gel | 2014-03-14 |
KULZER GMBH [KULZER, LLC] | Gluma Etch 35 Gel | 2014-03-14 |
KULZER GMBH [KULZER, LLC] | Palpress Vario | 2014-02-24 |
KULZER GMBH [KULZER, LLC] | Durafill VS | 2013-11-12 |
KULZER GMBH [KULZER, LLC] | Signum Connector | 2013-10-23 |
KULZER GMBH [KULZER, LLC] | Signum Insulating Gel | 2013-10-23 |
KULZER GMBH [KULZER, LLC] | PALA cre-active | 2013-10-23 |
KULZER GMBH [KULZER, LLC] | Premium | 2013-07-23 |
KULZER GMBH [KULZER, LLC] | Mondial i DS | 2013-07-23 |
KULZER GMBH [KULZER, LLC] | Mondial I | 2013-07-23 |
KULZER GMBH [KULZER, LLC] | Palaseal | 2013-07-11 |
KULZER GMBH [KULZER, LLC] | Charisma | 2013-06-17 |
KULZER GMBH [KULZER, LLC] | Paladon 65 | 2013-06-03 |
KULZER GMBH [KULZER, LLC] | ibond Etch 35 Fluid | 2013-05-28 |
KULZER GMBH [KULZER, LLC] | Gluma Etch 35 Fluid | 2013-05-28 |
KULZER GMBH [KULZER, LLC] | Gluma Solid Bond | 2013-04-10 |
KULZER GMBH [KULZER, LLC] | Gluma Desensitizer | 2013-04-10 |
KULZER GMBH [KULZER, LLC] | Palabond | 2013-04-10 |
KULZER GMBH [KULZER, LLC] | iBond Self Etch | 2013-04-10 |
KULZER GMBH [KULZER, LLC] | Venus Pearl | 2013-04-10 |
KULZER GMBH [KULZER, LLC] | Venus Pearl ONE | 2013-04-10 |
KULZER GMBH [KULZER, LLC] | Palaxpress Ultra | 2013-04-10 |
KULZER GMBH [KULZER, LLC] | Venus Diamond Flow | 2013-04-10 |
KULZER GMBH [KULZER, LLC] | Venus Bulk Fill | 2013-04-10 |
KULZER GMBH [KULZER, LLC] | Venus Diamond Flow | 2013-04-10 |
KULZER GMBH [KULZER, LLC] | Venus Bulk Fill | 2013-04-10 |
KULZER GMBH [KULZER, LLC] | iBond Total Etch | 2013-04-10 |
KULZER GMBH [KULZER, LLC] | Gluma Comfort Bond + Desensitizer | 2013-04-10 |
KULZER GMBH [KULZER, LLC] | iBond Total Etch | 2013-04-10 |
KULZER GMBH [KULZER, LLC] | Gluma Comfort Bond + Desensitizer | 2013-04-10 |
KULZER GMBH [KULZER, LLC] | Venus Diamond | 2013-04-10 |
KULZER GMBH [KULZER, LLC] | Venus Diamond ONE | 2013-04-10 |
KULZER GMBH [KULZER, LLC] | Venus | 2013-04-10 |
KULZER GMBH [KULZER, LLC] | Charisma ABC | 2013-04-10 |
KULZER GMBH [KULZER, LLC] | Gluma Power Gel KNA Sample | 2011-05-10 |
KULZER GMBH [KULZER, LLC] | Gluma Desensitizer PowerGel | 2011-05-10 |
KULZER GMBH [KULZER, LLC] | GPG KNA Sample | 2011-05-10 |
KULZER GMBH [KULZER, LLC] | Gluma Comfort Bond | 2009-06-15 |
KULZER GMBH [KULZER, LLC] | VENUS FLOW | 2006-09-20 |
KULZER GMBH [KULZER, LLC] | Charisma Flow | 2006-09-20 |
KULZER GMBH [KULZER, LLC] | Mondial DS | 2006-09-15 |
KULZER GMBH [KULZER, LLC] | MONDIAL | 2006-09-15 |
KULZER GMBH [KULZER, LLC] | Mixing Tips: Green | 1996-06-11 |
KULZER GMBH [KULZER, LLC] | Flow Canules | 1996-06-11 |
KULZER GMBH [KULZER, LLC] | Flexitime dynamix mixing tips | 1996-06-11 |
NCAGE Code | D8789 | KULZER GMBH |
CAGE Code | D8789 | KULZER GMBH HERAEUS KULZER PROSTHETICS |
Import ID | Shipment | Cargo Description | Quantity |
---|---|---|---|
2020080572690 | Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina | DENTAL PRODUCTS | 20 PKG |
2020072345651 | Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina | DENTAL PRODUCTS HS CODE: 34070000 | 14 PKG |
2020071641548 | Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina | DENTAL PRODUCTS HS 34070000 | 20 PKG |
2020052747348 | Bremerhaven,Federal Republic of Germany -> Charleston, South Carolina | DENTAL PRODUCTS CONTAINS DANGEROUS GOODS | 38 PKG |
2020031654694 | Bremerhaven,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. II | 12 PCS |
2020030314304 | Bremerhaven,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 QTY | 21 PCS |
2020022830390 | Bremerhaven,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 C | 18 PCS |
2020020566020 | Bremerhaven,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 QTY | 21 PCS |