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 Number	3010564008
FEI Number	3010564008
Name	David Furr
Owner & Operator	Denken - Highdental Co Ltd
Contact Address	130 Ishigoricho-cho Oyaki, Yamashina-ku Kyoto JP-26 Kyoto 607-8187 JP
Official Correspondent	Masaki Ichii 81-75-5711000-x
US Agent	David Furr FDC Services, LLC 512 9069654 davidfurr@fdcservices.com
Registration Status	1
Initial Importer	N
Registration Expiration	2020-04-25
Registration Address	8708 Capehart Cv Austin, TX 78733 US
Establishment Type	Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
GUDID 04560230234072 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-08-21
GUDID 04560230234065 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-08-21
GUDID 04560230234058 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-08-21
GUDID 04560230234041 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-08-21
GUDID 04560230234034 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-08-21
GUDID 04560230234027 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-08-21
GUDID 04560230234010 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-08-21
GUDID 04560230234003 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-08-21
GUDID 04560230233990 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-08-21
GUDID 04560230233983 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-07-10
GUDID 04560230233976 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-07-10
GUDID 04560230233969 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-07-10
GUDID 04560230233952 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-07-10
GUDID 04560230233945 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-07-10
GUDID 04560230233938 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-07-10
GUDID 04560230233921 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-07-10
GUDID 04560230233914 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-07-10
GUDID 04560230233907 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-07-10
GUDID 04560230233808 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-06-26
GUDID 04560230233792 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-06-26
GUDID 04560230233785 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-06-26
GUDID 04560230233778 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-06-26
GUDID 04560230233761 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-06-26
GUDID 04560230233754 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-06-26
GUDID 04560230233747 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-06-26
GUDID 04560230233730 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-06-26
GUDID 04560230233723 DENKEN-HIGHDENTAL CO., LTD.	KDF Zirconia Disc	2023-06-26
PMN K221429 DENKEN-HIGHDENTAL Co., Ltd.	KDF Zirconia Disc	2022-07-14
PMN K130680 \| EBI David Furr [Denken - Highdental Co Ltd]	Super Primer	2013-12-23
PMN K130680 \| EBI 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 Primer	2013-12-23
PMN K130680 \| EBI David Furr [Denken - Highdental Co Ltd]	AcryFlex, FlexFit, ClearFit, TurboFix, QuickBase	2013-12-23
EGD David Furr [Denken - Highdental Co Ltd]	Kolben Wax, Sprue Wax	2013-12-23

Related Finance Registrations

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2019122763251	Kobe,Japan -> Los Angeles, California	TURBOFIX 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:3006.40	2 CTN
2019121934350	Kobe,Japan -> Los Angeles, California	FLEXFIT(REZEN NF)& ETC . . .	36 CTN
2019113067822	Kobe,Japan -> Los Angeles, California	TURBOFIX LIQUID 1L BOTTLE ISO FAST LIQUID HS CODE:3006.40	2 CTN
2019072551783	Nagoya Ko ,Japan -> Los Angeles, California	FLEXFIT(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
2019032023094	Kobe,Japan -> Long Beach, California	ACRYTONE 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 MODEL	40 CTN
2019031828649	Kobe,Japan -> Long Beach, California	ACRYTONE 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 MODEL	40 CTN
2018070325300	Kobe,Japan -> Long Beach, California	ISO RESIN FLOW FOR DENTSOLL MODEL ISO RESIN F LOW FOR DENTSOLL MODEL SAMPLE DETAILS AS PER	27 PCS
2018062933957	Kobe,Japan -> Long Beach, California	ISO RESIN FLOW FOR DENTSOLL MODEL ISO RESIN F LOW FOR DENTSOLL MODEL SAMPLE DETAILS AS PER	27 PCS