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 | VENUS Diamond FLOW 66100306 | 2024-11-01 |
Kulzer GmbH | VENUS Diamond FLOW 66100275 | 2024-11-01 |
Kulzer GmbH | VENUS Diamond FLOW 66100274 | 2024-11-01 |
Kulzer GmbH | VENUS Diamond FLOW 66100273 | 2024-11-01 |
Kulzer GmbH | VENUS Diamond FLOW 66100272 | 2024-11-01 |
Kulzer GmbH | VENUS Diamond FLOW 66100271 | 2024-11-01 |
Kulzer GmbH | VENUS Diamond FLOW 66100270 | 2024-11-01 |
Kulzer GmbH | VENUS Diamond FLOW 66100269 | 2024-11-01 |
Kulzer GmbH | VENUS Diamond FLOW 66100268 | 2024-11-01 |
Kulzer GmbH | VENUS Diamond FLOW SYR 1 x 1,8G - HKA5 66040361 | 2024-10-30 |
Kulzer GmbH | VENUS Diamond FLOW SYR 1 x 1,8G - A4 66040360 | 2024-10-30 |
Kulzer GmbH | VENUS Diamond FLOW SYR 1 x 1,8G - A3.5 66040359 | 2024-10-30 |
Kulzer GmbH | VENUS Diamond FLOW SYR 1 x 1,8G - A3 66040358 | 2024-10-30 |
Kulzer GmbH | VENUS Diamond FLOW SYR 1 x 1,8G - HKA2.5 66040357 | 2024-10-30 |
Kulzer GmbH | VENUS Diamond FLOW SYR 1 x 1,8G - A2 66040355 | 2024-10-30 |
Kulzer GmbH | VENUS Diamond FLOW SYR 1 x 1,8G - A1 66040354 | 2024-10-30 |
Kulzer GmbH | VENUS Diamond FLOW SYR ASSORTMENT 66040353 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND PLT REFILL 1x10x0,25G YO 66039030 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND PLT REFILL 1x10x0,25G CO 66039029 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND PLT REFILL 1x10x0,25G AM 66039028 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND PLT REFILL 1x10x0,25G CL 66039027 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND PLT REFILL 1x10x0,25G BXL 66039026 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND PLT REFILL 1x10x0,25G BL 66039025 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND PLT REFILL 1x10x0,25G OB 66039024 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND PLT REFILL 1x10x0,25G D3 66039020 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND PLT REFILL 1x10x0,25G C3 66039019 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND PLT REFILL 2x10x0,25G C2 66039018 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND PLT REFILL 1x10x0,25G B3 66039017 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND PLT REFILL 2x10x0,25G B2 66039016 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND PLT REFILL 2x10x0,25G B1 66039015 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND PLT REFILL 1x10x0,25G HKA5 66039014 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND PLT REFILL 1x10x0,25G A4 66039013 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND PLT REFILL 2x10x0,25G A3,5 66039012 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND PLT REFILL 2x10x0,25G A3 66039011 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND PLT REF.2x10x0,25G HKA2,5 66039010 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND PLT REFILL 2x10x0,25G A2 66039009 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND PLT REFILL 2x10x0,25G A1 66039008 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND SYRINGE REFILL 1x4G YO 66035493 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND SYRINGE REFILL 1x4G CO 66035492 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND SYRINGE REFILL 1x4G AM 66035491 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND SYRINGE REFILL 1x4G CL 66035490 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND SYRINGE REFILL 1x4G OB 66035489 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND SYRINGE REFILL 1x4G BXL 66035488 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND SYRINGE REFILL 1x4G BL 66035487 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND SYRINGE REFILL 1x4G D3 66035483 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND SYRINGE REFILL 1x4G C3 66035482 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND SYRINGE REFILL 1x4G C2 66035481 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND SYRINGE REFILL 1x4G B3 66035480 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND SYRINGE REFILL 1x4G B2 66035479 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND SYRINGE REFILL 1x4G B1 66035478 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND SYRINGE REFILL 1x4G HKA5 66035477 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND SYRINGE REFILL 1x4G A4 66035476 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND SYRINGE REFILL 1x4G A3,5 66035475 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND SYRINGE REFILL 1x4G A3 66035474 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND SYRINGE REFILL 1x4G HKA2,5 66035473 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND SYRINGE REFILL 1x4G A2 66035472 | 2024-10-30 |
Kulzer GmbH | VENUS DIAMOND SYRINGE REFILL 1x4G A1 66035471 | 2024-10-30 |
Kulzer GmbH | PALA cre-active, gum, 3 g 66033468 | 2024-10-30 |
Kulzer GmbH | PALA cre-active, gingiva, light pink, 3 66033466 | 2024-10-30 |
Kulzer GmbH | PALA cre-active, gingiva, R 50, 3 g 66033465 | 2024-10-30 |
Kulzer GmbH | PALA cre-active, gingiva, shade 200, 3 g 66033464 | 2024-10-30 |
Kulzer GmbH | PALA cre-active, gingiva, pink 3 g 66033463 | 2024-10-30 |
Kulzer GmbH | PALA cre-active, black, 3 g 66033462 | 2024-10-30 |
Kulzer GmbH | PALA cre-active, maroon, 3 g 66033461 | 2024-10-30 |
Kulzer GmbH | PALA cre-active, red, 3 g 66033450 | 2024-10-30 |
Kulzer GmbH | PALA cre-active, pink, 3 g 66033449 | 2024-10-30 |
Kulzer GmbH | PALA cre-active, polar, 3 g 66033448 | 2024-10-30 |
Kulzer GmbH | PALA cre-active, white, 3 g 66033447 | 2024-10-30 |
Kulzer GmbH | PALA cre-active (assortment) 66033445 | 2024-10-30 |
Kulzer GmbH | ST Basic 8, CE 66030385 | 2024-10-30 |
Kulzer GmbH | ST Basic 6, CE 66030384 | 2024-10-30 |
Kulzer GmbH | Mondial 8, B1 / 35L, CE 66017348 | 2024-10-30 |
Kulzer GmbH | VENUS FLOW SYR 1 x 1,8G - T2 66014575 | 2024-10-30 |
Kulzer GmbH | VENUS FLOW SYR 1 x 1,8G BASELINER WHITE 66014574 | 2024-10-30 |
Kulzer GmbH | VENUS FLOW SYR 1 x 1,8G - SB1 66014571 | 2024-10-30 |
Kulzer GmbH | VENUS FLOW SYR 1 x 1,8G - OA2 66014570 | 2024-10-30 |
Kulzer GmbH | VENUS FLOW SYR 1 x 1,8G - B3 66014569 | 2024-10-30 |
Kulzer GmbH | VENUS FLOW SYR 1 x 1,8G - B2 66014568 | 2024-10-30 |
Kulzer GmbH | VENUS FLOW SYR 1 x 1,8G - A4 66014567 | 2024-10-30 |
Kulzer GmbH | VENUS FLOW SYR 1 x 1,8G - A3,5 66014566 | 2024-10-30 |
Kulzer GmbH | VENUS FLOW SYR 1 x 1,8G - A3 66014565 | 2024-10-30 |
Kulzer GmbH | VENUS FLOW SYR 1 x 1,8G - HKA2,5 66014564 | 2024-10-30 |
Kulzer GmbH | VENUS FLOW SYR 1 x 1,8G - A2 66014563 | 2024-10-30 |
Kulzer GmbH | VENUS FLOW SYR 1 x 1,8G - A1 66014562 | 2024-10-30 |
Kulzer GmbH | SOPIRA CITOJECT PLASTIC SLEEVE 1.8ML 1PC 66005419 | 2024-10-30 |
Kulzer GmbH | SOPIRA CITOJECT BARR ANG 1.8ML/INCH LA 66002394 | 2024-10-30 |
Kulzer GmbH | SOPIRA CITOJECT BARR STR 1.8ML/INCH LA 66002393 | 2024-10-30 |
Kulzer GmbH | SOPIRA CITOJECT SET 1.8ML/INCH FLAT LA 66002392 | 2024-10-30 |
Kulzer GmbH | CHARISMA SYR 1 x 4G - C3 66000094 | 2024-10-30 |
Kulzer GmbH | Palabond, 45 ml 64708082 | 2024-10-30 |
Kulzer GmbH | Palaseal, 2 x 15ml 64708063 | 2024-10-30 |
Kulzer GmbH | Paladon 65, R 50 veined, 1000 g 64707711 | 2024-10-30 |
Kulzer GmbH | Paladon 65, clear, 1000 g 64707710 | 2024-10-30 |
Kulzer GmbH | Paladon 65, pink veined, 1000 g 64707708 | 2024-10-30 |
Kulzer GmbH | Paladon 65, pink, 1000 g 64707706 | 2024-10-30 |
Kulzer GmbH | Paladon 65, 500 ml 64707674 | 2024-10-30 |
Kulzer GmbH | DYNAMIX MIXING TIPS (1 X 50) 60035999 | 2024-10-30 |
Kulzer GmbH | Basic living Mould Chart A3 50740009 | 2024-10-30 |
Kulzer GmbH | CK BITE YELLOW ECONOMY 50095194 | 2024-10-30 |
Kulzer GmbH | DYNAMIX MIXING TIPS (1 X 50) 40004353 | 2024-10-30 |
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 |