Sewon Medix Inc

FDA Filings

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

FDA Registration(s)
Registration Number3013271380
FEI Number3013271380
NameSEWON MEDIX, INC.
Owner & OperatorSewon Medix, Inc.
Contact Address#29, Sasang-ro, 375 beon-gil, Sasang-gu
Busan KR-26 Busan Gwangyeogsi 46946 KR
Official Correspondent
  • Jinsoo Lee
  • 82-51-3031713-x
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address#29, Sasang-ro, 375 beon-gil, Sasang-gu
Busan Busan Gwangyeogsi, 46946 KR
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
sewon medix Inc.
XP-I SLA Fixture BIH2FR5015S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FR5013S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FR5011S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FR5010S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FR5008S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FR5007S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FR4515S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FR4513S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FR4511S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FR4510S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FR4508S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FR4507S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FR4015S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FR4013S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FR4011S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FR4010S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FR4008S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FR4007S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FR3515S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FR3513S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FR3511S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FR3510S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FR3508S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FR3507S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FM3515S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FM3513S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FM3511S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FM3510S2022-02-24
sewon medix Inc.
XP-I SLA Fixture BIH2FM3508S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FR5015S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FR5013S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FR5011S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FR5010S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FR5008S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FR5007S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FR4515S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FR4513S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FR4511S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FR4510S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FR4508S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FR4507S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FR4015S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FR4013S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FR4011S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FR4010S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FR4008S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FR4007S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FR3515S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FR3513S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FR3511S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FR3510S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FR3508S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FR3507S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FM3515S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FM3513S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FM3511S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FM3510S2022-02-24
sewon medix Inc.
XP-I SLA Fixture AIH2FM3508S2022-02-24
sewon medix Inc.
Screw Driver for Ratchet RHD123L2020-12-21
sewon medix Inc.
IH Fixture Lab Analog IHFLAR120D2020-12-21
sewon medix Inc.
IH Transfer Impression Coping AIHTIMH40142020-12-21
sewon medix Inc.
IH Transfer Impression Coping AIHTIMH40112020-12-21
sewon medix Inc.
IH FreeMilling Abutment AIHFMRH6030D2020-12-21
sewon medix Inc.
IH FreeMilling Abutment AIHFMRH5530D2020-12-21
sewon medix Inc.
IH FreeMilling Abutment AIHFMRH5520D2020-12-21
sewon medix Inc.
IH FreeMilling Abutment AIHFMRH5510D2020-12-21
sewon medix Inc.
IH Cement Abutment AIHCARH5540LD2020-12-21
sewon medix Inc.
IH Cement Abutment AIHCARH5530LD2020-12-21
sewon medix Inc.
IH Cement Abutment AIHCARH4510MC2020-03-11
sewon medix Inc.
IH Cement Abutment 2020-03-05
sewon medix Inc.
IH Cement Abutment AIHCARH4530M2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCARH4520M2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCAMH4540M2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCAMH4530M2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCAMH4520M2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCAMH4510M2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCARH6040LC2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCARH6030LC2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCARH6020LC2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCARH6030MC2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCARH6020MC2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCARH6010MC2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCARH6030SC2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCARH6020SC2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCARH6010SC2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCARH5050LC2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCARH5040LC2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCARH5030LC2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCARH5040MC2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCARH5030MC2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCARH5020MC2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCARH5040SC2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCARH5030SC2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCARH5020SC2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCARH4540MC2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCARH4530MC2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCARH4520MC2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCAMH4540MC2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCAMH4520MC2019-11-08
sewon medix Inc.
IH Cement Abutment AIHCAMH4510MC2019-11-08
SEWON MEDIX, INC.
Wrench (Ratchet Wrench, Torque Wrench)2016-11-08
SEWON MEDIX, INC.
Surgical KIT2016-11-08
SEWON MEDIX, INC.
Plastic Impression Coping & Cylinder (IH Solid Impression Coping, IH Solid Burn-out Cylinder)2016-11-08
SEWON MEDIX, INC.
MULTI-UNIT TRANSFER IMPRESSION COPING(AMTIC450, AMTIC550)2016-11-08
SEWON MEDIX, INC.
MULTI-UNIT PICK-UP IMPRESSION COPING(AMPIC480H, AMPIC480S, AMPIC450H, AMPIC450S, AMPIC550H, AMPIC550S)2016-11-08
SEWON MEDIX, INC.
MULTI-UNIT LAB ANALOG(MLA480, MLA450, MLA550)2016-11-08
SEWON MEDIX, INC.
Lab Analog (IH Solid, IH2 Fixture, Multi-unit)2016-11-08
SEWON MEDIX, INC.
Instruments (Parallel Pin, Tissue Punch)2016-11-08
SEWON MEDIX, INC.
Impression Coping (IH Pick-up, IH Transfer, Multi-unit Transfer, Multi-unit Pick-up)2016-11-08
SEWON MEDIX, INC.
IH TRANSFER IMPRESSION COPING(AIHTIRH6511, AIHTIRH6514, AIHTIRH4511D, AIHTIRH4514D, AIHTIRH5011D, AIHTIRH5014D)2016-11-08
SEWON MEDIX, INC.
IH TRANSFER IMPRESSION COPING(AIHTIRH5511D, AIHTIRH5514D, AIHTIRH6011D, AIHTIRH6014D, AIHTIRH6511D, AIHTIRH6514D)2016-11-08
SEWON MEDIX, INC.
IH TRANSFER IMPRESSION COPING(AIHTIRH5011, AIHTIRH5014, AIHTIRH5511, AIHTIRH5514, AIHTIRH6011, AIHTIRH6014)2016-11-08
SEWON MEDIX, INC.
IH TRANSFER IMPRESSION COPING(AIHTIMH4011, AIHTIMH4014, AIHTIMH4511, AIHTIMH4514, AIHTIRH4511, AIHTIRH4514)2016-11-08
SEWON MEDIX, INC.
IH SOLID LAB ANALOG(IHSLA55S, IHSLA55M, IHSLA55L, IHSLA60S, IHSLA60M, IHSLA60L, IHSLA65S, IHSLA65M, IHSLA65L)2016-11-08
SEWON MEDIX, INC.
IH SOLID LAB ANALOG(IHSLA40S, IHSLA40M, IHSLA40L, IHSLA45S, IHSLA45M, IHSLA45L, IHSLA50S, IHSLA50M, IHSLA50L)2016-11-08
SEWON MEDIX, INC.
IH SOLID IMPRESSION COPING(IHSIC40, IHSIC45, IHSIC50, IHSIC55, IHSIC60, IHSIC65)2016-11-08
SEWON MEDIX, INC.
IH SOLID BURN-OUT CYLINDER(IHSBC55S, IHSBC55B, IHSBC60S, IHSBC60B, IHSBC65S, IHSBC65B)2016-11-08
SEWON MEDIX, INC.
IH SOLID BURN-OUT CYLINDER(IHSBC40S, IHSBC40B, IHSBC45S, IHSBC45B, IHSBC50S, IHSBC50B)2016-11-08
SEWON MEDIX, INC.
IH IMPRESSION COPING(AIHPIRN6511, AIHPIRN6515)2016-11-08
SEWON MEDIX, INC.
IH IMPRESSION COPING(AIHPIRN5011, AIHPIRN5015, IHPIRN5511, IHPIRN5515, AIHPIRN6011, AIHPIRN6015)2016-11-08
SEWON MEDIX, INC.
IH IMPRESSION COPING(AIHPIRH6015, AIHPIRH6511, AIHPIRH6515)2016-11-08
SEWON MEDIX, INC.
IH IMPRESSION COPING(AIHPIRH6011D, AIHPIRH6015D, AIHPIRH6511D, AIHPIRH6515D)2016-11-08
SEWON MEDIX, INC.
IH IMPRESSION COPING(AIHPIRH5011, AIHPIRH5015, AIHPIRH5511, AIHPIRH5515, AIHPIRH6011)2016-11-08
SEWON MEDIX, INC.
IH IMPRESSION COPING(AIHPIRH4511D, AIHPIRH4515D, AIHPIRH5011D, AIHPIRH5015D, AIHPIRH5511D, AIHPIRH5515D)2016-11-08
SEWON MEDIX, INC.
IH IMPRESSION COPING(AIHPIMN4011, AIHPIMN4015, IHPIMN4511, IHPIMN4515, AIHPIRN4511, AIHPIRN4515)2016-11-08
SEWON MEDIX, INC.
IH IMPRESSION COPING(AIHPIMH4011, AIHPIMH4015, IHPIMH4511, IHPIMH4515, AIHPIRH4511, AIHPIRH4515)2016-11-08
SEWON MEDIX, INC.
IH FIXTURE LAB ANALOG(IHFLAM120, IHFLAR120, IHFLAR120D, IHFLAM150, IHFLAR150, IHFLAR150D)2016-11-08
SEWON MEDIX, INC.
Driver (Fixture Driver, Screw Driver, Hand Driver, Solid Driver)2016-11-08
SEWON MEDIX, INC.
TORQUE WRENCH(STW30S, STW30SS, STW50S, STW50SS, STW80S, STW80SS)2016-11-08
SEWON MEDIX, INC.
TORQUE WRENCH(STW30B, STW30BS, STW50B, STW50BS, STW80B, STW80BS)2016-11-08
SEWON MEDIX, INC.
SOLID DRIVER(IHSD40, IHSD45, IHSD50, IHSD55, IHSD60, IHSD65)2016-11-08
SEWON MEDIX, INC.
SCREW DRIVER FOR RATCHET(RHD128S, RHD128M, RHD128L, RSD120S, RSD120M, RSD120L, RIHD20S, RIHD20, RIHD20L)2016-11-08
SEWON MEDIX, INC.
SCREW DRIVER FOR RATCHET(RHD120S, RHD120M, RHD120L, RHD123S, RHD123M, RHD123L, RHD125S, RHD125M, RHD125L)2016-11-08
SEWON MEDIX, INC.
SCREW DRIVER FOR MACHINE(MHD128S, MHD128M, MHD128L, MSD120S, MSD120M, MSD120L, MIHD20S, MIHD20, MIHD20L)2016-11-08
SEWON MEDIX, INC.
SCREW DRIVER FOR MACHINE(MHD120S, MHD120M, MHD120L, MHD123S, MHD123M, MHD123L, MHD125S, MHD125M, MHD125L)2016-11-08
SEWON MEDIX, INC.
RATCHET WRENCH(SRW, SRW400)2016-11-08
SEWON MEDIX, INC.
PARALLEL PIN(SPP40, SPP45, SPP50, SPP55, SPP60, SPP65)2016-11-08
SEWON MEDIX, INC.
OPEN WRENCH(OW700)2016-11-08
SEWON MEDIX, INC.
MOUNT DRIVER(FMDMS, FMDMM, FMDML, FMDRS, FMDRM, FMDRL)2016-11-08
SEWON MEDIX, INC.
HAND DRIVER(SDH128S, SDH128M, SDH128L, SDHS120S, SDHS120M, SDHS120L)2016-11-08
SEWON MEDIX, INC.
HAND DRIVER(SDH120S, SDH120M, SDH120L, SDH123S, SDH123M, SDH123L, SDH125S, SDH125M, SDH125L)2016-11-08
SEWON MEDIX, INC.
FIXTURE DRIVER FOR RATCHET(IHRFD21S, IHRFD21L, IHRFD25S, IHRFD25L)2016-11-08
SEWON MEDIX, INC.
FIXTURE DRIVER FOR MACHINE(IHMFD21S, IHMFD21L, IHMFD25S, IHMFD25L)2016-11-08
SEWON MEDIX, INC.
Depth Gauge2016-11-08
SEWON MEDIX, INC.
DRIVER CONNECTOR(DCS100, DCM120)2016-11-08
SEWON MEDIX, INC.
DRILL STOPPER(DS507, DS508, DS510, DS511, DS513, DS515, DS607, DS608, DS610, DS611, DS613, DS615)2016-11-08
SEWON MEDIX, INC.
DEPTH GAUGE(SDG)2016-11-08
SEWON MEDIX, INC.
TISSUE PUNCH(STP33, STP38, STP43, STP48, STP53, STP63)2016-11-08
SEWON MEDIX, INC.
SURGICAL TAP(IHFTR35, IHFTR37, IHFTR40, IHFTR45, IHFTR50, IHFTR60)2016-11-08
SEWON MEDIX, INC.
SURGICAL TAP(IHFTM35, IHFTM37, IHFTM40, IHFTM45, IHFTM50, IHFTM602016-11-08
SEWON MEDIX, INC.
SURGICAL KIT-K7(STK7B, STK7S, SEK7B, SEK7S, SPK7B, SPK7S)2016-11-08
SEWON MEDIX, INC.
SURGICAL KIT-K5(STK5B, STK5BT, STK5S, SEK5B, SEK5BT, SEK5S, SPK5B, SPK5S)2016-11-08
SEWON MEDIX, INC.
SURGICAL KIT-K3(STK3B, STK3S, SEK3B, SEK3S, SPK3B, SPK3S)2016-11-08
SEWON MEDIX, INC.
SURGICAL KIT(SFK, SSK)2016-11-08
SEWON MEDIX, INC.
STRAIGHT DRILL(ST4307, ST4308, ST4310, ST4311, ST4313, ST5307, ST5308, ST5310, ST5311, ST5313)2016-11-08
SEWON MEDIX, INC.
STRAIGHT DRILL(ST3807, ST3808, ST3810, ST3811, ST3813)2016-11-08
SEWON MEDIX, INC.
STRAIGHT DRILL(ST3007, ST3008, ST3010, ST3011, ST3013, ST3307, ST3308, ST3310, ST3311, ST3313)2016-11-08
SEWON MEDIX, INC.
STRAIGHT DRILL(ST2207, ST2208, ST2210, ST2211, ST2213, ST2707, ST2708, ST2710, ST2711, ST2713)2016-11-08
SEWON MEDIX, INC.
STRAIGHT DRILL FOR STOPPER(TS2D2217, TS3D3017, TS3D3317, TS3D3817, TS3D4317)2016-11-08
SEWON MEDIX, INC.
STRAIGHT DRILL FOR STOPPER(, TS3D5317, STS2215, STS2715, STS3015, STS3315, STS3815, STS4315, STS5315)2016-11-08
SEWON MEDIX, INC.
STOPPER DRILL KIT(DKT, DKP, DKE, SDK)2016-11-08
SEWON MEDIX, INC.
STEP DRILL(SP435307, SP435308, SP435310, SP435311, SP435313)2016-11-08
SEWON MEDIX, INC.
STEP DRILL(SP333807, SP333808, SP333810, SP333811, SP333813, SP384307, SP384308, SP384310, SP384311, SP384313)2016-11-08
SEWON MEDIX, INC.
STEP DRILL(SP223007, SP223008, SP223010, SP223011, SP223013, SP303307, SP303308, SP303310, SP303311, SP303313)2016-11-08
SEWON MEDIX, INC.
STEP DRILL FOR STOPPER(SPS3843L, SPS4353S, SPS4353L)2016-11-08
SEWON MEDIX, INC.
STEP DRILL FOR STOPPER(SPS2230S, SPS2230L, SPS3033S, SPS3033L, SPS3338S, SPS3338L, SPS3843S)2016-11-08
SEWON MEDIX, INC.
PROSTHETICS KIT-K5(PK5S, PK5B, SPK)2016-11-08
SEWON MEDIX, INC.
PROSTHETICS KIT-128(PK128S, PK128B, PK128SS, PK128BS)2016-11-08
SEWON MEDIX, INC.
PROSTHETICS KIT-125(PK125S, PK125B, PK125SS, PK125BS)2016-11-08
SEWON MEDIX, INC.
PROSTHETICS KIT-123(PK123S, PK123B, PK123BS)2016-11-08
SEWON MEDIX, INC.
PROSTHETICS KIT-120(PK120S, PK120B, PK120SS, PK120BS)2016-11-08
SEWON MEDIX, INC.
PILOT DRILL(SPD30, SPD33, SPD38, SPD43)2016-11-08
SEWON MEDIX, INC.
GUIDE DRILL(SGD21), DRILL EXTENSION(SDE260)2016-11-08
SEWON MEDIX, INC.
EXTRA DRILL(EA5307, EA5308, EA5310, EA5311, EA5313, FD5513, FD5013)2016-11-08
SEWON MEDIX, INC.
EXTRA DRILL(EA3807, EA3808, EA3810, EA3811, EA3813, EA4307, EA4308, EA4310, EA4311, EA4313)2016-11-08
SEWON MEDIX, INC.
EXTRA DRILL(EA3007, EA3008, EA3010, EA3011, EA3013, EA3307, EA3308, EA3310, EA3311, EA3313)2016-11-08
SEWON MEDIX, INC.
EXTRA DRILL FOR STOPPER(EAS3015S, EAS3315S, EAS3815S, EAS4315S, EAS5315S)2016-11-08
SEWON MEDIX, INC.
EXTRA DRILL FOR STOPPER(EAS3015L, EAS3315L, EAS3815L, EAS4315L, EAS5315L)2016-11-08
SEWON MEDIX, INC.
Drill & Drill Accessories (Sidecut Drill, Bone Profiler, Trephine Drill)2016-11-08
SEWON MEDIX, INC.
Drill & Drill Accessories (Guide Drill, Drill Extension, Twist Drill, Pilot Drill, Cortical Drill, Drill Stopper)2016-11-08
SEWON MEDIX, INC.
IH Implant System2016-11-01
SEWON MEDIX, INC.
IH Implant System2016-11-01
Sewon Medix Inc.
IH Implant System2016-10-14

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