Manufacturer registered with FDA

Sewon Medix, Inc.

Busan, South Korea. Lists 6 dental device types with FDA across 1 registered establishment, and holds 2 510(k) clearances as applicant.

FDA owner/operator10053110Manufacturer1 clearance in five years

Device types listed: 6
Brands and models: 101
510(k) clearances: 22016–2023
Markets registered in: 41,287 registrations outside the US
Establishments: 1South Korea

510(k) clearances per year, 2007–2026

Registered in 4 markets

Where regulators' registries name Sewon Medix, Inc. as the manufacturer or the registration holder of a device.

All markets

RegisteredHome: South KoreaOne marker per market

Market	Regulator	Named as	Name on the registry	Registrations	Issued	Records
United States	FDA	Manufacturer	Sewon Medix, Inc.	2 clearances	2016–2023	Below
European Union	EUDAMED	Manufacturer	SEWONMEDIX Inc.	1,285	—	Pure Global AI
China	NMPA	Registration holder	世元公司SEWONMEDIX INC.	1	—	Pure Global AI
Egypt	EDA	Manufacturer	SEWONMEDIX Inc.,	1	2026–2026	Pure Global AI

Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026

Devices listed with FDA

What Sewon Medix, Inc. currently lists, by FDA device type, with the brand and model names on the listing.

Device type	Category	Role	Brands and models	Listed since
Root-Form Endosseous ImplantDZE · Class 2	Dental implants	Maker	BIOTHREAD BT3 Implant SystemIH Implant System	2016
Endosseous Dental Implant AbutmentNHA · Class 2	Implant abutments	Maker	BIOTHREAD BT3 Implant SystemIH Implant System	2016
Intraoral Dental DrillDZA · Class 1	Surgical drills & motors	Maker	BONE TRIMMER (SBT50)Drill & Drill Accessories (Guide Drill, Drill Extension, Twist Drill, Pilot Drill, Cortical Drill, Drill Stopper)Drill & Drill Accessories (Sidecut Drill, Bone Profiler, Trephine Drill)EXPANDER DRILL (SEP162808, SEP162810, SEP162811, SEP223608, SEP223610, SEP223611)EXPANDER DRILL (SEP274108, SEP274110, SEP274111, SEP314508, SEP314510, SEP314511)EXPANDER KIT (SEPK3B)EXTRA DRILL FOR STOPPER(EAS3015L, EAS3315L, EAS3815L, EAS4315L, EAS5315L)EXTRA DRILL FOR STOPPER(EAS3015S, EAS3315S, EAS3815S, EAS4315S, EAS5315S)EXTRA DRILL(EA3007, EA3008, EA3010, EA3011, EA3013, EA3307, EA3308, EA3310, EA3311, EA3313)EXTRA DRILL(EA3807, EA3808, EA3810, EA3811, EA3813, EA4307, EA4308, EA4310, EA4311, EA4313) 34 more EXTRA DRILL(EA5307, EA5308, EA5310, EA5311, EA5313, FD5513, FD5013)GUIDE DRILL(SGD21), DRILL EXTENSION(SDE260)PILOT DRILL(SPD30, SPD33, SPD38, SPD43)PROSTHETICS KIT-120(PK120S, PK120B, PK120SS, PK120BS)PROSTHETICS KIT-123(PK123S, PK123B, PK123BS)PROSTHETICS KIT-125(PK125S, PK125B, PK125SS, PK125BS)PROSTHETICS KIT-128(PK128S, PK128B, PK128SS, PK128BS)PROSTHETICS KIT-K5(PK5S, PK5B, SPK)SAW (SSAW70)SEWONGUIDE EXTRA DRILL (SGEA3007, SGEA3008, SGEA3010, SGEA3011, SGEA3013)SEWONGUIDE EXTRA DRILL (SGEA3307, SGEA3308, SGEA3310, SGEA3311, SGEA3313)SEWONGUIDE EXTRA DRILL (SGEA3807, SGEA3808, SGEA3810, SGEA3811, SGEA3813)SEWONGUIDE EXTRA DRILL (SGEA4307, SGEA4308, SGEA4310, SGEA4311, SGEA4313)SEWONGUIDE INITIAL DRILL (SGST2207, SGST2208, SGST2210, SGST2211, SGST2213)SEWONGUIDE KIT (SGK5B)STEP DRILL FOR STOPPER(SPS2230S, SPS2230L, SPS3033S, SPS3033L, SPS3338S, SPS3338L, SPS3843S)STEP DRILL FOR STOPPER(SPS3843L, SPS4353S, SPS4353L)STEP DRILL(SP223007, SP223008, SP223010, SP223011, SP223013, SP303307, SP303308, SP303310, SP303311, SP303313)STEP DRILL(SP333807, SP333808, SP333810, SP333811, SP333813, SP384307, SP384308, SP384310, SP384311, SP384313)STEP DRILL(SP435307, SP435308, SP435310, SP435311, SP435313)STOPPER DRILL KIT(DKT, DKP, DKE, SDK)STRAIGHT DRILL FOR STOPPER(, TS3D5317, STS2215, STS2715, STS3015, STS3315, STS3815, STS4315, STS5315)STRAIGHT DRILL FOR STOPPER(TS2D2217, TS3D3017, TS3D3317, TS3D3817, TS3D4317)STRAIGHT DRILL(ST2207, ST2208, ST2210, ST2211, ST2213, ST2707, ST2708, ST2710, ST2711, ST2713)STRAIGHT DRILL(ST3007, ST3008, ST3010, ST3011, ST3013, ST3307, ST3308, ST3310, ST3311, ST3313)STRAIGHT DRILL(ST3807, ST3808, ST3810, ST3811, ST3813)STRAIGHT DRILL(ST4307, ST4308, ST4310, ST4311, ST4313, ST5307, ST5308, ST5310, ST5311, ST5313)SURGICAL KIT-K3(STK3B, STK3S, SEK3B, SEK3S, SPK3B, SPK3S)SURGICAL KIT-K5(STK5B, STK5BT, STK5S, SEK5B, SEK5BT, SEK5S, SPK5B, SPK5S)SURGICAL KIT-K7(STK7B, STK7S, SEK7B, SEK7S, SPK7B, SPK7S)SURGICAL KIT(SFK, SSK)SURGICAL TAP(IHFTM35, IHFTM37, IHFTM40, IHFTM45, IHFTM50, IHFTM60SURGICAL TAP(IHFTR35, IHFTR37, IHFTR40, IHFTR45, IHFTR50, IHFTR60)TISSUE PUNCH(STP33, STP38, STP43, STP48, STP53, STP63)	2016
Dental Instrument Depth GaugeEIL · Class 1	Dental hand instruments	Maker	Depth GaugeDEPTH GAUGE(SDG)DRILL STOPPER(DS507, DS508, DS510, DS511, DS513, DS515, DS607, DS608, DS610, DS611, DS613, DS615)DRIVER CONNECTOR(DCS100, DCM120)FIXTURE DIRVER FOR MACHINE (IHMFD25RS, IHMFD525RL, SGMFD21, SGMFD25R, SGMFD25)FIXTURE DIRVER FOR RATCHET (IHRFD25RS, IHRFD525RL, SGRFD21, SGRFD25R, SGRFD25)FIXTURE DRIVER FOR MACHINE(IHMFD21S, IHMFD21L, IHMFD25S, IHMFD25L)FIXTURE DRIVER FOR RATCHET(IHRFD21S, IHRFD21L, IHRFD25S, IHRFD25L)GUIDE REAMER (SGRE52)HAND DRIVER(SDH120S, SDH120M, SDH120L, SDH123S, SDH123M, SDH123L, SDH125S, SDH125M, SDH125L) 12 more HAND DRIVER(SDH128S, SDH128M, SDH128L, SDHS120S, SDHS120M, SDHS120L)MOUNT DRIVER(FMDMS, FMDMM, FMDML, FMDRS, FMDRM, FMDRL)OPEN WRENCH(OW700)PARALLEL PIN(SPP40, SPP45, SPP50, SPP55, SPP60, SPP65)RATCHET WRENCH(SRW, SRW400)SCREW DRIVER FOR MACHINE(MHD120S, MHD120M, MHD120L, MHD123S, MHD123M, MHD123L, MHD125S, MHD125M, MHD125L)SCREW DRIVER FOR MACHINE(MHD128S, MHD128M, MHD128L, MSD120S, MSD120M, MSD120L, MIHD20S, MIHD20, MIHD20L)SCREW DRIVER FOR RATCHET(RHD120S, RHD120M, RHD120L, RHD123S, RHD123M, RHD123L, RHD125S, RHD125M, RHD125L)SCREW DRIVER FOR RATCHET(RHD128S, RHD128M, RHD128L, RSD120S, RSD120M, RSD120L, RIHD20S, RIHD20, RIHD20L)SOLID DRIVER(IHSD40, IHSD45, IHSD50, IHSD55, IHSD60, IHSD65)TORQUE WRENCH(STW30B, STW30BS, STW50B, STW50BS, STW80B, STW80BS)TORQUE WRENCH(STW30S, STW30SS, STW50S, STW50SS, STW80S, STW80SS)	2016
Resin ApplicatorKXR · Class 1	—	Maker	Plastic Coping (CPC450B, CPC450S)	2022
Endosseous Dental Implant AccessoriesNDP · Class 1	Implant instruments & surgical kits	Maker	Driver (Fixture Driver, Screw Driver, Hand Driver, Solid Driver)Fixture Mount (IHFMM35, IHFMR37, IHFMR40)IH FIXTURE LAB ANALOG(IHFLAM120, IHFLAR120, IHFLAR120D, IHFLAM150, IHFLAR150, IHFLAR150D)IH IMPRESSION COPING(AIHPIMH4011, AIHPIMH4015, IHPIMH4511, IHPIMH4515, AIHPIRH4511, AIHPIRH4515)IH IMPRESSION COPING(AIHPIMN4011, AIHPIMN4015, IHPIMN4511, IHPIMN4515, AIHPIRN4511, AIHPIRN4515)IH IMPRESSION COPING(AIHPIRH4511D, AIHPIRH4515D, AIHPIRH5011D, AIHPIRH5015D, AIHPIRH5511D, AIHPIRH5515D)IH IMPRESSION COPING(AIHPIRH5011, AIHPIRH5015, AIHPIRH5511, AIHPIRH5515, AIHPIRH6011)IH IMPRESSION COPING(AIHPIRH6011D, AIHPIRH6015D, AIHPIRH6511D, AIHPIRH6515D)IH IMPRESSION COPING(AIHPIRH6015, AIHPIRH6511, AIHPIRH6515)IH IMPRESSION COPING(AIHPIRN5011, AIHPIRN5015, IHPIRN5511, IHPIRN5515, AIHPIRN6011, AIHPIRN6015) 20 more IH IMPRESSION COPING(AIHPIRN6511, AIHPIRN6515)IH SOLID BURN-OUT CYLINDER(IHSBC40S, IHSBC40B, IHSBC45S, IHSBC45B, IHSBC50S, IHSBC50B)IH SOLID BURN-OUT CYLINDER(IHSBC55S, IHSBC55B, IHSBC60S, IHSBC60B, IHSBC65S, IHSBC65B)IH SOLID IMPRESSION COPING(IHSIC40, IHSIC45, IHSIC50, IHSIC55, IHSIC60, IHSIC65)IH SOLID LAB ANALOG(IHSLA40S, IHSLA40M, IHSLA40L, IHSLA45S, IHSLA45M, IHSLA45L, IHSLA50S, IHSLA50M, IHSLA50L)IH SOLID LAB ANALOG(IHSLA55S, IHSLA55M, IHSLA55L, IHSLA60S, IHSLA60M, IHSLA60L, IHSLA65S, IHSLA65M, IHSLA65L)IH TRANSFER IMPRESSION COPING(AIHTIMH4011, AIHTIMH4014, AIHTIMH4511, AIHTIMH4514, AIHTIRH4511, AIHTIRH4514)IH TRANSFER IMPRESSION COPING(AIHTIRH5011, AIHTIRH5014, AIHTIRH5511, AIHTIRH5514, AIHTIRH6011, AIHTIRH6014)IH TRANSFER IMPRESSION COPING(AIHTIRH5511D, AIHTIRH5514D, AIHTIRH6011D, AIHTIRH6014D, AIHTIRH6511D, AIHTIRH6514D)IH TRANSFER IMPRESSION COPING(AIHTIRH6511, AIHTIRH6514, AIHTIRH4511D, AIHTIRH4514D, AIHTIRH5011D, AIHTIRH5014D)Impression Coping (IH Pick-up, IH Transfer, Multi-unit Transfer, Multi-unit Pick-up)Instruments (Parallel Pin, Tissue Punch)Lab Analog (IH Solid, IH2 Fixture, Multi-unit)LT Abutment Carrier (LTPC180)MULTI-UNIT LAB ANALOG(MLA480, MLA450, MLA550)MULTI-UNIT PICK-UP IMPRESSION COPING(AMPIC480H, AMPIC480S, AMPIC450H, AMPIC450S, AMPIC550H, AMPIC550S)MULTI-UNIT TRANSFER IMPRESSION COPING(AMTIC450, AMTIC550)Plastic Impression Coping & Cylinder (IH Solid Impression Coping, IH Solid Burn-out Cylinder)Surgical KITWrench (Ratchet Wrench, Torque Wrench)	2016

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026

510(k) clearances

Clearances on which FDA names Sewon Medix, Inc. as the applicant.

Decided	510(k)	Device	Device type
7 Jul 2023	K222707	IH Implant System	DZE Root-Form Endosseous Implant
14 Oct 2016	K153521	IH Implant System	DZE Root-Form Endosseous Implant

Registered establishments

Establishment	Location	What it does
SEWON MEDIX, INC.FDA reg. 3013271380	Busan, South Korea	Manufacturer

Sources

FDA establishment registration & device listing (search FDA, owner/operator 10053110). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.