SEWON MEDIX, INC.

FDA Device Registration & Listing · Busan, KR · Registration 3013271380

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013271380
FEI Number
3013271380
Entity Name
SEWON MEDIX, INC.
City/State/Country
Busan, KR
Establishment Address
#29, Sasang-ro, 375 beon-gil, Sasang-gu, Busan 46946, KR
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Sewon Medix, Inc. (Owner Number: 10053110)
Owner / Operator Contact Address
#29, Sasang-ro, 375 beon-gil, Sasang-gu, Busan, KR-26 46946, KR
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Depth Gauge TORQUE WRENCH(STW30B, STW30BS, STW50B, STW50BS, STW80B, STW80BS) SCREW DRIVER FOR RATCHET(RHD120S, RHD120M, RHD120L, RHD123S, RHD123M, RHD123L, RHD125S, RHD125M, RHD125L) HAND DRIVER(SDH120S, SDH120M, SDH120L, SDH123S, SDH123M, SDH123L, SDH125S, SDH125M, SDH125L) PARALLEL PIN(SPP40, SPP45, SPP50, SPP55, SPP60, SPP65) HAND DRIVER(SDH128S, SDH128M, SDH128L, SDHS120S, SDHS120M, SDHS120L) FIXTURE DRIVER FOR MACHINE(IHMFD21S, IHMFD21L, IHMFD25S, IHMFD25L) MOUNT DRIVER(FMDMS, FMDMM, FMDML, FMDRS, FMDRM, FMDRL) SCREW DRIVER FOR MACHINE(MHD128S, MHD128M, MHD128L, MSD120S, MSD120M, MSD120L, MIHD20S, MIHD20, MIHD20L) SCREW DRIVER FOR MACHINE(MHD120S, MHD120M, MHD120L, MHD123S, MHD123M, MHD123L, MHD125S, MHD125M, MHD125L) DRILL STOPPER(DS507, DS508, DS510, DS511, DS513, DS515, DS607, DS608, DS610, DS611, DS613, DS615) SOLID DRIVER(IHSD40, IHSD45, IHSD50, IHSD55, IHSD60, IHSD65) SCREW DRIVER FOR RATCHET(RHD128S, RHD128M, RHD128L, RSD120S, RSD120M, RSD120L, RIHD20S, RIHD20, RIHD20L) FIXTURE DRIVER FOR RATCHET(IHRFD21S, IHRFD21L, IHRFD25S, IHRFD25L) DRIVER CONNECTOR(DCS100, DCM120) OPEN WRENCH(OW700) RATCHET WRENCH(SRW, SRW400) DEPTH GAUGE(SDG) TORQUE WRENCH(STW30S, STW30SS, STW50S, STW50SS, STW80S, STW80SS) FIXTURE DIRVER FOR RATCHET (IHRFD25RS, IHRFD525RL, SGRFD21, SGRFD25R, SGRFD25) GUIDE REAMER (SGRE52) FIXTURE DIRVER FOR MACHINE (IHMFD25RS, IHMFD525RL, SGMFD21, SGMFD25R, SGMFD25) Driver (Fixture Driver, Screw Driver, Hand Driver, Solid Driver) Surgical KIT Wrench (Ratchet Wrench, Torque Wrench) Impression Coping (IH Pick-up, IH Transfer, Multi-unit Transfer, Multi-unit Pick-up) Plastic Impression Coping & Cylinder (IH Solid Impression Coping, IH Solid Burn-out Cylinder) Instruments (Parallel Pin, Tissue Punch) Lab Analog (IH Solid, IH2 Fixture, Multi-unit) IH SOLID LAB ANALOG(IHSLA40S, IHSLA40M, IHSLA40L, IHSLA45S, IHSLA45M, IHSLA45L, IHSLA50S, IHSLA50M, IHSLA50L) IH TRANSFER IMPRESSION COPING(AIHTIRH5511D, AIHTIRH5514D, AIHTIRH6011D, AIHTIRH6014D, AIHTIRH6511D, AIHTIRH6514D) IH IMPRESSION COPING(AIHPIRH6015, AIHPIRH6511, AIHPIRH6515) MULTI-UNIT PICK-UP IMPRESSION COPING(AMPIC480H, AMPIC480S, AMPIC450H, AMPIC450S, AMPIC550H, AMPIC550S) IH IMPRESSION COPING(AIHPIMH4011, AIHPIMH4015, IHPIMH4511, IHPIMH4515, AIHPIRH4511, AIHPIRH4515) IH SOLID BURN-OUT CYLINDER(IHSBC55S, IHSBC55B, IHSBC60S, IHSBC60B, IHSBC65S, IHSBC65B) IH TRANSFER IMPRESSION COPING(AIHTIRH6511, AIHTIRH6514, AIHTIRH4511D, AIHTIRH4514D, AIHTIRH5011D, AIHTIRH5014D) IH IMPRESSION COPING(AIHPIRH4511D, AIHPIRH4515D, AIHPIRH5011D, AIHPIRH5015D, AIHPIRH5511D, AIHPIRH5515D) IH FIXTURE LAB ANALOG(IHFLAM120, IHFLAR120, IHFLAR120D, IHFLAM150, IHFLAR150, IHFLAR150D) IH IMPRESSION COPING(AIHPIRN5011, AIHPIRN5015, IHPIRN5511, IHPIRN5515, AIHPIRN6011, AIHPIRN6015) IH SOLID BURN-OUT CYLINDER(IHSBC40S, IHSBC40B, IHSBC45S, IHSBC45B, IHSBC50S, IHSBC50B) IH TRANSFER IMPRESSION COPING(AIHTIRH5011, AIHTIRH5014, AIHTIRH5511, AIHTIRH5514, AIHTIRH6011, AIHTIRH6014) IH IMPRESSION COPING(AIHPIRH6011D, AIHPIRH6015D, AIHPIRH6511D, AIHPIRH6515D) IH IMPRESSION COPING(AIHPIRN6511, AIHPIRN6515) MULTI-UNIT LAB ANALOG(MLA480, MLA450, MLA550) IH IMPRESSION COPING(AIHPIMN4011, AIHPIMN4015, IHPIMN4511, IHPIMN4515, AIHPIRN4511, AIHPIRN4515) IH SOLID IMPRESSION COPING(IHSIC40, IHSIC45, IHSIC50, IHSIC55, IHSIC60, IHSIC65) IH SOLID LAB ANALOG(IHSLA55S, IHSLA55M, IHSLA55L, IHSLA60S, IHSLA60M, IHSLA60L, IHSLA65S, IHSLA65M, IHSLA65L) MULTI-UNIT TRANSFER IMPRESSION COPING(AMTIC450, AMTIC550) IH TRANSFER IMPRESSION COPING(AIHTIMH4011, AIHTIMH4014, AIHTIMH4511, AIHTIMH4514, AIHTIRH4511, AIHTIRH4514) IH IMPRESSION COPING(AIHPIRH5011, AIHPIRH5015, AIHPIRH5511, AIHPIRH5515, AIHPIRH6011) Fixture Mount (IHFMM35, IHFMR37, IHFMR40) LT Abutment Carrier (LTPC180) Drill & Drill Accessories (Sidecut Drill, Bone Profiler, Trephine Drill) Drill & Drill Accessories (Guide Drill, Drill Extension, Twist Drill, Pilot Drill, Cortical Drill, Drill Stopper) STRAIGHT DRILL(ST2207, ST2208, ST2210, ST2211, ST2213, ST2707, ST2708, ST2710, ST2711, ST2713) PILOT DRILL(SPD30, SPD33, SPD38, SPD43) SURGICAL KIT-K7(STK7B, STK7S, SEK7B, SEK7S, SPK7B, SPK7S) STRAIGHT DRILL(ST4307, ST4308, ST4310, ST4311, ST4313, ST5307, ST5308, ST5310, ST5311, ST5313) STRAIGHT DRILL FOR STOPPER(, TS3D5317, STS2215, STS2715, STS3015, STS3315, STS3815, STS4315, STS5315) EXTRA DRILL(EA5307, EA5308, EA5310, EA5311, EA5313, FD5513, FD5013) EXTRA DRILL FOR STOPPER(EAS3015S, EAS3315S, EAS3815S, EAS4315S, EAS5315S) PROSTHETICS KIT-K5(PK5S, PK5B, SPK) SURGICAL KIT(SFK, SSK) GUIDE DRILL(SGD21), DRILL EXTENSION(SDE260) STEP DRILL(SP333807, SP333808, SP333810, SP333811, SP333813, SP384307, SP384308, SP384310, SP384311, SP384313) SURGICAL TAP(IHFTR35, IHFTR37, IHFTR40, IHFTR45, IHFTR50, IHFTR60) PROSTHETICS KIT-128(PK128S, PK128B, PK128SS, PK128BS) PROSTHETICS KIT-123(PK123S, PK123B, PK123BS) STEP DRILL FOR STOPPER(SPS3843L, SPS4353S, SPS4353L) SURGICAL KIT-K3(STK3B, STK3S, SEK3B, SEK3S, SPK3B, SPK3S) SURGICAL KIT-K5(STK5B, STK5BT, STK5S, SEK5B, SEK5BT, SEK5S, SPK5B, SPK5S) PROSTHETICS KIT-120(PK120S, PK120B, PK120SS, PK120BS) STEP DRILL FOR STOPPER(SPS2230S, SPS2230L, SPS3033S, SPS3033L, SPS3338S, SPS3338L, SPS3843S) STOPPER DRILL KIT(DKT, DKP, DKE, SDK) STRAIGHT DRILL FOR STOPPER(TS2D2217, TS3D3017, TS3D3317, TS3D3817, TS3D4317) EXTRA DRILL FOR STOPPER(EAS3015L, EAS3315L, EAS3815L, EAS4315L, EAS5315L) PROSTHETICS KIT-125(PK125S, PK125B, PK125SS, PK125BS) STEP DRILL(SP223007, SP223008, SP223010, SP223011, SP223013, SP303307, SP303308, SP303310, SP303311, SP303313) STRAIGHT DRILL(ST3807, ST3808, ST3810, ST3811, ST3813) SURGICAL TAP(IHFTM35, IHFTM37, IHFTM40, IHFTM45, IHFTM50, IHFTM60 EXTRA DRILL(EA3007, EA3008, EA3010, EA3011, EA3013, EA3307, EA3308, EA3310, EA3311, EA3313) EXTRA DRILL(EA3807, EA3808, EA3810, EA3811, EA3813, EA4307, EA4308, EA4310, EA4311, EA4313) STRAIGHT DRILL(ST3007, ST3008, ST3010, ST3011, ST3013, ST3307, ST3308, ST3310, ST3311, ST3313) TISSUE PUNCH(STP33, STP38, STP43, STP48, STP53, STP63) STEP DRILL(SP435307, SP435308, SP435310, SP435311, SP435313) SEWONGUIDE EXTRA DRILL (SGEA3007, SGEA3008, SGEA3010, SGEA3011, SGEA3013) EXPANDER KIT (SEPK3B) EXPANDER DRILL (SEP274108, SEP274110, SEP274111, SEP314508, SEP314510, SEP314511) SAW (SSAW70) EXPANDER DRILL (SEP162808, SEP162810, SEP162811, SEP223608, SEP223610, SEP223611) SEWONGUIDE EXTRA DRILL (SGEA3307, SGEA3308, SGEA3310, SGEA3311, SGEA3313) SEWONGUIDE EXTRA DRILL (SGEA3807, SGEA3808, SGEA3810, SGEA3811, SGEA3813) SEWONGUIDE INITIAL DRILL (SGST2207, SGST2208, SGST2210, SGST2211, SGST2213) SEWONGUIDE EXTRA DRILL (SGEA4307, SGEA4308, SGEA4310, SGEA4311, SGEA4313) SEWONGUIDE KIT (SGK5B) BONE TRIMMER (SBT50) IH Implant System IH Implant System BIOTHREAD BT3 Implant System Plastic Coping (CPC450B, CPC450S)

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
EIL Gauge, Depth, Instrument, Dental Dental Class 1 872.4565 2016-11-08
NDP Accessories, Implant, Dental, Endosseous Dental Class 1 872.3980 2016-11-08
DZA Drill, Dental, Intraoral Dental Class 1 872.4130 2016-11-08
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2016-11-01
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2016-11-01
DZE Implant, Endosseous, Root-Form Dental Class 2 872.3640 2023-07-24
NHA Abutment, Implant, Dental, Endosseous Dental Class 2 872.3630 2023-07-24
KXR Applicator, Resin Dental Class 1 872.3140 2022-07-05

Official Correspondent

Jinsoo Lee

US Agent Details

April Lee Email: withus6664@gmail.com Phone: (909) 2749971

Related Public Records

Same Entity

Sewon Medix, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K081806 Idi Biomedical, LLC IDI IMPLANT SYSTEM 2008-11-07
K120793 Z-Systems AG Z-LOOK3 EVO SLM 2012-12-21
K130140 Intra-Lock International INTRA-LOCK OP DENTAL IMPLANT 2013-08-01
K925778 Nobelpharma USA, Inc. BRANEMARK SYSTEM LAB. AND EDUCATIONAL ACCESSORIES 1993-04-14
K903999 O Co., Inc. OBUTMENT HB 1992-02-11

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0013-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SP, Cat. No. 30-70101 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0014-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment NP, Cat. No. 30-70102 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0015-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment MU, Cat. No. 30-70103 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0016-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment SU, Cat. No. 30-70104 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.
Z-0017-2022 Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel 1
Scan Abutment PCA, Cat. No. 30-70105 - Product Usage: used to take an impression with an intra oral scanner or optical scanner to provide a digital registration of an implant or abutment platform. The Paltop Advanced Dental Solutions Implant System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient s chewing function.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013271380. Last updated year: 2026. Please use registration number 3013271380 when referencing this establishment in official correspondence.
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