Xenia Mardak

FDA Filings

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

FDA Registration(s)
Registration Number3006098230
FEI Number3006098230
NameXenia Mardak
Owner & OperatorSICAT GMBH & CO. KG
Contact AddressBRUNNENALLEE 6 --
BONN DE-NOTA 53177 DE
Official Correspondent
  • Manfred - Breuer
  • 49-228-854697-82
US Agent
Importing Logistics Registration
Importer19th Street Dental
Address232 19th street NW, ste 7200
Atlanta, GA 30363 UNITED STATES
Importing Logistics Registration
Importer3020 Dental Associates
Address3020 W Montrose Ave
Chicago, IL 60618 UNITED STATES
Importing Logistics Registration
Importer360 Dental Care
Address3660 Stoneridge # B101
Austin, TX 78746 UNITED STATES
Importing Logistics Registration
Importer44th St Dental
Address3925 W. 44th St.
Minneapolis, MN 55424 UNITED STATES
Importing Logistics Registration
ImporterA2Z Dental Group
Address9929 Topanga Canyon Blvd
Chatsworth, CA 91311 UNITED STATES
Importing Logistics Registration
ImporterAbenaki Dental Care
Address1 Hampton Rd Suite #305
Exeter, NH 03833 UNITED STATES
Importing Logistics Registration
ImporterAbington Center
Address116 North State Street
Clarks Summit, PA 18411 UNITED STATES
Importing Logistics Registration
ImporterAbington Dental Arts, P.C.
Address242 Noble Rd.
Clarks Summit, PA 18411 UNITED STATES
Importing Logistics Registration
ImporterAdams Dental Group
Address8911 State Ave
Kansas City, KS 66104 UNITED STATES
Importing Logistics Registration
ImporterAdult Dentistry of Ballantyne
Address7820 Ballantyne Commons Pkwy #102
Charlotte, NC 28277 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1825 Pine St, #6
San Francisco, CA 94109 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device
  • Foreign Private Label Distributor
  • Repack or Relabel Medical Device
  • Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device
Company
DeviceDate
Xenia Mardak [SICAT GMBH & CO. KG]
SICAT IMPLANT V2.02019-12-06
Xenia Mardak [SICAT GMBH & CO. KG]
Meisinger Rotary Root Canal Burs2018-07-06
Xenia Mardak [SICAT GMBH & CO. KG]
Meisinger Endo Access Burs2018-07-06
Xenia Mardak [SICAT GMBH & CO. KG]
SICAT ACCESSGUIDE2018-05-17
Xenia Mardak [SICAT GMBH & CO. KG]
SICAT Endo2018-03-27
Xenia Mardak [SICAT GMBH & CO. KG]
SICAT OPTISLEEP2016-04-04
Xenia Mardak [SICAT GMBH & CO. KG]
OPTISLEEP2016-04-04
Xenia Mardak [SICAT GMBH & CO. KG]
SICAT OPTISLEEP2016-04-04
Xenia Mardak [SICAT GMBH & CO. KG]
OPTISLEEP2016-04-04
Xenia Mardak [SICAT GMBH & CO. KG]
SICAT Air2015-12-17
Xenia Mardak [SICAT GMBH & CO. KG]
SICAT OPTIMOTION2015-12-17
Xenia Mardak [SICAT GMBH & CO. KG]
SICAT Function2014-03-04
Xenia Mardak [SICAT GMBH & CO. KG]
SICAT JMT+2013-10-22
Xenia Mardak [SICAT GMBH & CO. KG]
SICAT Implant2011-05-25
Xenia Mardak [SICAT GMBH & CO. KG]
GALILEOS Implant2010-01-04
Xenia Mardak [SICAT GMBH & CO. KG]
SICAT Sleeve2007-05-18
Xenia Mardak [SICAT GMBH & CO. KG]
SICAT SURGICAL GUIDE2007-05-18
Xenia Mardak [SICAT GMBH & CO. KG]
SICAT OPTIGUIDE2007-05-18
Xenia Mardak [SICAT GMBH & CO. KG]
SICAT DIGITALGUIDE2007-05-18
Xenia Mardak [SICAT GMBH & CO. KG]
SICAT CLASSICGUIDE2007-05-18
Xenia Mardak [SICAT GMBH & CO. KG]
SICAT Bite Plate (Kit)2007-05-18
Xenia Mardak [SICAT GMBH & CO. KG]
GALILEOS SURGICAL GUIDE2007-05-18

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