Kulzer S R L

FDA Filings

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

FDA Registration(s)

• Registration Number: 3011203516
• FEI Number: 3011203516
• Name: Kulzer SRL
• Owner & Operator: KULZER, LLC
• Contact Address: 4315 S. Lafayette Blvd. ; South Bend IN 46614 US
• Official Correspondent:
  • Marc A Henn
  • 1-574-2995444-x
• US Agent:
  • Marc Henn
  • KULZER, LLC
  • 574 2995444
  • Marc.Henn@Kulzer-dental.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Claderia 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	Device	Date
PMN K760755 | ELW Kulzer SRL [KULZER, LLC]	Cuttersil Puttly Plus	2016-09-07
PMN K760755 | ELW Kulzer SRL [KULZER, LLC]	Cuttersil Light	2016-09-07
PMN K971155 | ELW Kulzer SRL [KULZER, LLC]	Memoreg, Memoreg 2	2014-03-25
PMN K902115 | EBI Kulzer SRL [KULZER, LLC]	Palpress Vario	2014-02-24
PMN K130647 | ELW Kulzer SRL [KULZER, LLC]	Xantasil	2013-09-09
PMN K080338 | ELW Kulzer SRL [KULZER, LLC]	Cutter Hardener	2013-08-12
PMN K080338 | ELW Kulzer SRL [KULZER, LLC]	Cutter Activator	2013-08-12
PMN K901789 | EBI Kulzer SRL [KULZER, LLC]	Paladon 65	2013-06-03
PMN K000629 | ELW Kulzer SRL [KULZER, LLC]	Flexitime	2013-05-28
PMN K991425 | ELW Kulzer SRL [KULZER, LLC]	XANTOPREN COMFORT	2013-04-11
PMN K973694 | ELW Kulzer SRL [KULZER, LLC]	PROVIL NOVO	2013-04-11
PMN K913537 | ELW Kulzer SRL [KULZER, LLC]	MEMOSIL	2013-04-11
PMN K910165 | ELW Kulzer SRL [KULZER, LLC]	CUTTERSIL MUCOSA	2013-04-11
PMN K120914 | ELW Kulzer SRL [KULZER, LLC]	FLEXITIME FAST & SCAN LIGHT FLOW	2013-04-11
PMN K113574 | ELW Kulzer SRL [KULZER, LLC]	FLEXITIME MONOPHASE PRO SCAN	2013-04-11
PMN K102770 | ELW Kulzer SRL [KULZER, LLC]	FLEXITME FAST & SCAN MEDIUM FLOW	2013-04-11
PMN K102770 | ELW Kulzer SRL [KULZER, LLC]	FLEXITIME FAST & SCAN PUTTY	2013-04-11
PMN K101617 | ELW Kulzer SRL [KULZER, LLC]	FLEXITIME XTREME 2	2013-04-11
PMN K091494 | ELW Kulzer SRL [KULZER, LLC]	FLEXITIME FLOW	2013-04-11
PMN K082591 | ELW Kulzer SRL [KULZER, LLC]	Flexitime Bite	2013-04-11
PMN K003930 | ELW Kulzer SRL [KULZER, LLC]	FLEXITIME MAGNUM 360	2013-04-11
PMN K110037 | EBI Kulzer SRL [KULZER, LLC]	Palaxpress Ultra	2013-04-10
IWZ Kulzer SRL [KULZER, LLC]	AGFA DENTUS FILM	1996-06-11
EID Kulzer SRL [KULZER, LLC]	Mixing Tips: Green	1996-06-11
EID Kulzer SRL [KULZER, LLC]	Flow Canules	1996-06-11
EID Kulzer SRL [KULZER, LLC]	Flexitime dynamix mixing tips	1996-06-11