Nikinc Dental B V

FDA Filings

This page includes the latest FDA filings for Nikinc Dental B V. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3010851243
FEI Number3010851243
NameMichael van de Woude
Owner & OperatorNIKINC DENTAL B.V.
Contact AddressZwaanstraat 31e
Eindhoven NL-NB Noord-Brabant 5651 CA NL
Official Correspondent
  • F.M. - VERHOEVEN
  • 31-634-162628-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address2500 Bee Cave Road Bldg 1, Suite 300
Austin, TX 78746 US
Establishment Type
  • Foreign Private Label Distributor
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device
Company
DeviceDate
Michael van de Woude [NIKINC DENTAL B.V.]
UseFill SmartTrack? Reciprocating Files X12015-04-14
Michael van de Woude [NIKINC DENTAL B.V.]
Endodontic file2015-04-14
Michael van de Woude [NIKINC DENTAL B.V.]
UseFill2014-06-02
Michael van de Woude [NIKINC DENTAL B.V.]
Obturator, obturator heater2014-06-02
Michael van de Woude [NIKINC DENTAL B.V.]
HyFlex2014-06-02
Michael van de Woude [NIKINC DENTAL B.V.]
RootBuddy2007-04-04
Michael van de Woude [NIKINC DENTAL B.V.]
EndoTwinn2007-04-04
Michael van de Woude [NIKINC DENTAL B.V.]
DownPak2007-04-04

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