Anaxdent North America

FDA Filings

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

Anaxdent North America holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

• CENDRES AND METAUX SA
• Tay Harvey

FDA Registration(s)

• Registration Number: 3009432160
• FEI Number: 3009432160
• Name: anaxdent North America
• Owner & Operator: anaxdent North America
• Contact Address: 406 I ST NW ; Ardmore OK 73401 US
• Official Correspondent:
  • Tay Harvey
  • 1-580-5805046-580
• Registration Status: 1
• Initial Importer: Y
• Registration Expiration: 2020-04-25
• Registration Address: 406 I ST NW ARDMORE ; Ardmore, OK 73401 US
• Establishment Type:
  • Complaint File Establishment per 21 CFR 820.198
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
PMN K173908 | NHA anaxdent North America	CM Connect	2019-03-07
PMN K170588 | NHA anaxdent North America	CM Connect	2019-03-07
PMN K981091 | ELW anaxdent North America	Celara Extended-Pour Alginate	2015-12-31
PMN K132937 | EBG anaxdent North America	anaxCAD	2015-12-31
PMN K123638 | EBG anaxdent North America	Pekkton Ivory	2015-12-31
PMN K052073 | EBI anaxdent North America	ACRYLINE	2013-04-04
PMN K112044 | EBF anaxdent North America	anaxPINK	2012-02-16
PMN K112044 | EBF anaxdent North America	anaxGUM	2012-02-16
PMN K112044 | EBF anaxdent North America	anaxBLEND	2012-02-16
PMN K112044 | EBF anaxdent North America	Mock-up Direct	2012-02-16
PMN K023079 | EBG anaxdent North America	anaxdent	2012-02-16
PMN K023079 | EBG anaxdent North America	New Outline	2012-02-16