Marc Henn

FDA Filings

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

FDA Registration(s)

• Registration Number: 3005665377
• FEI Number: 3005665377
• Name: Marc Henn
• 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: 4315 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 Number: 3013684905
• FEI Number: 3013684905
• Name: Marc Henn
• 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: 4315 S. Lafayette Blvd ; South Bend, IN 46614 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
NOF Marc Henn [KULZER, LLC]	Cara i500	2017-05-31
NOF Marc Henn [KULZER, LLC]	Cara i500	2017-05-31
NOF Marc Henn [KULZER, LLC]	Cara Scan 4.0i	2017-05-31
NOF Marc Henn [KULZER, LLC]	Cara Scan 4.0i	2017-05-31
NOF Marc Henn [KULZER, LLC]	Cara Scan 4.0	2017-05-31
NOF Marc Henn [KULZER, LLC]	Cara Scan 4.0	2017-05-31
NOF Marc Henn [KULZER, LLC]	Cara Scan 4.0 BUNDLE	2017-05-31
NOF Marc Henn [KULZER, LLC]	Cara Scan 4.0 BUNDLE	2017-05-31
NDP Marc Henn [KULZER, LLC]	Dima Print Guide	2017-05-31
DYT Marc Henn [KULZER, LLC]	Dima Print Ortho	2017-05-31
EJB Marc Henn [KULZER, LLC]	Kulzer PLT Applicator	2016-02-05
PMN K002993 | EIH Marc Henn [KULZER, LLC]	Heraceram	2013-05-06
EHJ Marc Henn [KULZER, LLC]	Venus Supra	2007-01-16
PMN K842006 | EJI Marc Henn [KULZER, LLC]	CITOJECT	2006-09-21
PMN K052543 | EIH Marc Henn [KULZER, LLC]	Heraeceram Zirkonia	2006-09-21
PMN K042199 | EBZ Marc Henn [KULZER, LLC]	Translux Wave	2006-09-21
PMN K042199 | EBZ Marc Henn [KULZER, LLC]	Translux 2 Wave	2006-09-21
PMN K042199 | EBZ Marc Henn [KULZER, LLC]	TRANSLUX POWER BLUE	2006-09-21
PMN K905058 | EBH Marc Henn [KULZER, LLC]	Pala Digital Impression Tray	2006-09-20
PMN K905058 | EBH Marc Henn [KULZER, LLC]	Dima Print Impression Blue	2006-09-20

Similar & Related FDA Registered Companies

• KULZER, LLC