Spident Co L T D

FDA Filings

This page includes the latest FDA filings for Spident 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: 3006113314
• FEI Number: 3006113314
• Name: SPIDENT CO., LTD.
• Owner & Operator: SPIDENT CO., LTD.
• Contact Address: 312, 151B-6L NAMDONGGONGDAN --; INCHEON KR-NOTA 405-821 KR
• US Agent:
  • Kwang Soon Choi
  • Spident USA, Inc.
  • 201 9440511
  • spident.usa@gmail.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 312, 151B-6L NAMDONGGONGDAN ; INCHEON Gyeonggido, 405-821 KR
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device
  • Export Device to the United States But Perform No Other Operation on Device

FDA Filings

Device Company	Device	Date
PMN K214071 SPIDENT CO., LTD.	Hexa-Temp	2022-03-10
GUDID 20210205180023 Spident Co., Ltd.	EsCom 100 B1 Syringe 101-0709	2021-01-26
GUDID 20200723170026 Spident Co., Ltd.	EsFlow LV A3 Syringe 101-0903	2021-01-26
GUDID 20200623170027 Spident Co., Ltd.	EsFlow LV A2 Syringe 101-0902	2021-01-26
GUDID 20200523170066 Spident Co., Ltd.	EsCom 100 A3.5 Capsules 101-0604	2021-01-26
GUDID 20191004160150 Spident Co., Ltd.	EsCom 100 B2 Capsules 101-0605	2021-01-26
GUDID 08809262959802 Spident Co., Ltd.	I-SiL Jumbo Regular Body 102-0601	2021-01-26
GUDID 08809262955576 Spident Co., Ltd.	EsCom 100 A1 Capsules 101-0601	2021-01-26
GUDID 08809262954524 Spident Co., Ltd.	Base It 101-0101	2021-01-26
GUDID 08809262954173 Spident Co., Ltd.	Tempro Blue 101-1501	2021-01-26
GUDID 00210205180012 Spident Co., Ltd.	EsCom100 A4 Syringe 101-0705	2021-01-26
GUDID 08809262959840 Spident Co., Ltd.	I-SIL Heavy Body Fast Set 102-0402	2019-09-30
GUDID 08809262959819 Spident Co., Ltd.	I-SIL Medium Body Regular Set 102-0301	2019-09-30
GUDID 08809262954722 Spident Co., Ltd.	EsFlow A2 Syringe 101-0802	2019-09-30
GUDID 08809262954715 Spident Co., Ltd.	EsFlow A1 Syringe 101-0801	2019-09-30
GUDID 08809262954166 Spident Co., Ltd.	Tempro Yellow 101-1502	2019-09-30
GUDID 08809262955323 Spident Co., Ltd.	EsCom 100 TW Syringe 101-0711	2019-07-01
GUDID 00210205180029 Spident Co., Ltd.	EsCom 100 C2 Syringe 101-0710	2019-07-01
GUDID 08809262959826 Spident Co., Ltd.	I-Sil Light Body Regular Set 102-0201	2019-05-31
GUDID 08809262955279 Spident Co., Ltd.	EsCom100 B2 Syringe 101-0708	2019-05-31
GUDID 08809262955224 Spident Co., Ltd.	EsCom100 A2 Syringe 101-0702	2019-05-31
GUDID 08809262955217 Spident Co., Ltd.	EsCom 100 A1 Syringe 101-0701	2019-05-31
GUDID 20200723170323 Spident Co., Ltd.	EsCom 100 A2 Capsules 101-0602	2019-05-17
GUDID 20200623170096 Spident Co., Ltd.	Estemp Implant Cement 101-1013	2019-05-17
GUDID 20200305180030 Spident Co., Ltd.	Estemp Eugenol Temporary Cement 101-1011	2019-05-17
GUDID 20190723160274 Spident Co., Ltd.	EsCom 100 A3 Capsules 101-0603	2019-05-17
GUDID 08809262959888 Spident Co., Ltd.	I-SIL Bite Registration Fast Set	2019-05-17
GUDID 08809262959871 Spident Co., Ltd.	I-SIL Bite Registration SP 102-0102	2019-05-17
GUDID 08809262959864 Spident Co., Ltd.	I-SIL Putty Fast Set	2019-05-17
GUDID 08809262959857 Spident Co., Ltd.	I-SIL Light Body HD Fast Set 102-0202	2019-05-17
GUDID 08809262959833 Spident Co., Ltd.	I-SIL Putty Regular Set 102-0501	2019-05-17
GUDID 08809262958034 Spident Co., Ltd.	I-SiL Jumbo Heavy Body	2019-05-17
GUDID 08809262955439 Spident Co., Ltd.	EsBond Activator 101-0502	2019-05-17
GUDID 08809262955415 Spident Co., Ltd.	EsBond 101-0501	2019-05-17
GUDID 08809262955248 Spident Co., Ltd.	EsCom100 A3.5 Syringe 101-0704	2019-05-17
GUDID 08809262955231 Spident Co., Ltd.	EsCom100 A3 Syringe 101-0703	2019-05-17
GUDID 08809262955033 Spident Co., Ltd.	I-SIL Heavy Body Regular Set	2019-05-17
GUDID 08809262954869 Spident Co., Ltd.	Core It White 101-0303	2019-05-17
GUDID 08809262954845 Spident Co., Ltd.	Core It Blue 101-0302	2019-05-17
GUDID 08809262954838 Spident Co., Ltd.	Core It Yellow 101-0301	2019-05-17
GUDID 08809262954760 Spident Co., Ltd.	EsFlow B2 Syringe 101-0805	2019-05-17
GUDID 08809262954746 Spident Co., Ltd.	EsFlow A3.5 Syringe 101-0804	2019-05-17
GUDID 08809262954739 Spident Co., Ltd.	EsFlow A3 Syringe 101-0803	2019-05-17
GUDID 08809262954227 Spident Co., Ltd.	Estemp NE Temporary Cement 101-1012	2019-05-17
GUDID 08809262954036 Spident Co., Ltd.	FineEtch 101-1201	2019-05-17
GUDID 02020072718045 Spident Co., Ltd.	I-SiL Jumbo Heavy Body Fast Set 102-0604	2019-05-17
PMN K161774 | ELW SPIDENT CO., LTD.	Vaccu-SiL	2016-12-16
PMN K161774 | ELW SPIDENT CO., LTD.	I-Sil	2016-12-16
PMN K161774 SPIDENT Co., Ltd.	I-Sil	2016-09-30
EIF SPIDENT CO., LTD.	Retraction Cord	2016-07-05
PMN K134021 | EMA SPIDENT CO., LTD.	EsTemp Implant	2016-05-02
PMN K134022 SPIDENT CO., LTD.	BASE IT	2014-06-11
PMN K134021 SPIDENT CO., LTD.	ESTEMP IMPLANT, ESTEMP CLEAR	2014-06-10
PMN K120768 | EBF SPIDENT CO., LTD.	Seal it	2012-05-29
PMN K120768 | EBF SPIDENT CO., LTD.	EsFlow	2012-05-29
PMN K120767 | KLE SPIDENT CO., LTD.	EsBond	2012-05-29
PMN K120767 SPIDENT CO., LTD.	ES BOND	2012-05-24
PMN K120768 SPIDENT CO., LTD.	ES FLOW	2012-05-03
PMN K992337 | FMC SPIDENT CO., LTD.	BLooming Gloves	2012-04-19
PMN K093751 | EBZ SPIDENT CO., LTD.	FOCUS	2012-04-19
PMN K023755 | FXX SPIDENT CO., LTD.	BLooming Masks	2012-04-19
EHY SPIDENT CO., LTD.	Spident Bite Tray	2012-04-19
DZM SPIDENT CO., LTD.	NOP Dental Needles	2012-04-19
NDP SPIDENT CO., LTD.	HoEtch 37%	2012-02-17
NDP SPIDENT CO., LTD.	FineEtch	2012-02-17
NDP SPIDENT CO., LTD.	FineEtch Pro	2012-02-17
EKQ SPIDENT CO., LTD.	SoftPrep	2012-02-17
EIE SPIDENT CO., LTD.	FineDam	2012-02-17
PMN K110428 | EBF SPIDENT CO., LTD.	Top Com	2011-10-31
PMN K110428 | EBF SPIDENT CO., LTD.	EsCom 100	2011-10-31
PMN K100413 | EBF SPIDENT CO., LTD.	Temp.it, Temp.ro, Temp.it Flow	2011-10-31
PMN K100290 | EMA SPIDENT CO., LTD.	ES Temp NE	2011-10-31
PMN K092572 | EBF SPIDENT CO., LTD.	Core It Dual	2011-10-31
PMN K110428 SPIDENT CO., LTD.	ESCOM 100	2011-02-25
PMN K100413 SPIDENT CO., LTD.	TEMP IT	2010-03-03
PMN K100290 SPIDENT CO., LTD.	ESTEMP NE	2010-02-17
PMN K092572 SPIDENT CO., LTD.	CORE*IT DUAL	2009-08-26
EKN SPIDENT CO., LTD.	PAPAER POINTS	2006-07-06
EKM SPIDENT CO., LTD.	GUTTA PERCHA POINTS	2006-07-06

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092818156	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	DENTAL FILLING MATERIAL 300640	15 PKG
2020072217867	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	DENTAL FILLING MATERIAL	19 CTN
2020033140481	Pusan,South Korea -> Long Beach, California	DENTAL FILLING MATERIAL	21 CTN
2020011717226	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	SCINTIGRAPHIC APPARATUS 9018.14	15 PKG
2020010377709	Pusan,South Korea -> Los Angeles, California	DENTAL FILLING MATERIAL USED FOR THE TEETH LA BEL-SPIDENT	13 CTN
2019120559569	Pusan,South Korea -> Los Angeles, California	DENTAL IMPRESSION MATERIAL	10 CTN
2019112124385	Pusan,South Korea -> New York/Newark Area, Newark, New Jersey	NEEDLES FOR INJECTIONS 9018.32	134 CTN
2019083151194	Pusan,South Korea -> Los Angeles, California	DENTAL FILLING MATERIAL	11 CTN