Denken Highdental Co L T D

FDA Filings

This page includes the latest FDA filings for Denken Highdental Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number3010564008
FEI Number3010564008
NameDavid Furr
Owner & OperatorDenken - Highdental Co Ltd
Contact Address130 Ishigoricho-cho Oyaki, Yamashina-ku
Kyoto JP-26 Kyoto 607-8187 JP
Official Correspondent
  • Masaki Ichii
  • 81-75-5711000-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address8708 Capehart Cv
Austin, TX 78733 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



FDA Filings

Device
Company
DeviceDate
DENKEN-HIGHDENTAL Co., Ltd.
KDF Zirconia Disc2022-07-14
David Furr [Denken - Highdental Co Ltd]
Super Primer2013-12-23
David Furr [Denken - Highdental Co Ltd]
Rezen NF, Acry Tone, Bio Tone, Acry Jet, Bio Plast, ISO Fast, ISO Resin-H, ISO Resin-Q, Resin Primer, Super Primer2013-12-23
David Furr [Denken - Highdental Co Ltd]
AcryFlex, FlexFit, ClearFit, TurboFix, QuickBase2013-12-23
David Furr [Denken - Highdental Co Ltd]
Kolben Wax, Sprue Wax2013-12-23

Related Finance Registrations
U.S. Import Records [external site]
Import IDShipmentCargo DescriptionQuantity
2019122763251Kobe,Japan -> Los Angeles, CaliforniaTURBOFIX LIQUID 1L BOTTLE ISO FAST LIQUID C/NO.1-LOT:191021-1 X 10PCS C/NO.2-LOT:191021-1 X 7PCS, 191021-2 X 3PCS HS CODE:3006.402 CTN
2019121934350Kobe,Japan -> Los Angeles, CaliforniaFLEXFIT(REZEN NF)& ETC . . .36 CTN
2019113067822Kobe,Japan -> Los Angeles, CaliforniaTURBOFIX LIQUID 1L BOTTLE ISO FAST LIQUID HS CODE:3006.402 CTN
2019072551783Nagoya Ko ,Japan -> Los Angeles, CaliforniaFLEXFIT(REZEN NF) #7A REAL PINK 1KG BIO TONE #7A (LOT: 1904227-1) TURBOFIX BASE POWDER #0 CLEAR 100G ISO FAST#0(LOT: 1905200) TURBOFIX BASE POWDER #7A 100G ISO FAST#7A(LOT: 1905207)9 CTN
2019032023094Kobe,Japan -> Long Beach, CaliforniaACRYTONE FOR DENTSOLL MODEL BIOTONE REZEN NF FOR DENTSOLL MODEL SPRUE WAX 5.5MM ISO FAST POWDER FOR DENTSOLL MODEL ISO RESIN Q POWDER FOR DENTSOLL MODEL ISO RESINFLOW FOR DENTSOLL MODEL40 CTN
2019031828649Kobe,Japan -> Long Beach, CaliforniaACRYTONE FOR DENTSOLL MODEL BIOTONE REZEN NF FOR DENTSOLL MODEL SPRUE WAX 5.5MM ISO FAST POWDER FOR DENTSOLL MODEL ISO RESIN Q POWDER FOR DENTSOLL MODEL ISO RESINFLOW FOR DENTSOLL MODEL40 CTN
2018070325300Kobe,Japan -> Long Beach, CaliforniaISO RESIN FLOW FOR DENTSOLL MODEL ISO RESIN F LOW FOR DENTSOLL MODEL SAMPLE DETAILS AS PER27 PCS
2018062933957Kobe,Japan -> Long Beach, CaliforniaISO RESIN FLOW FOR DENTSOLL MODEL ISO RESIN F LOW FOR DENTSOLL MODEL SAMPLE DETAILS AS PER27 PCS

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