FDA Registration
Active
🇰🇷 South Korea
SEWON MEDIX, INC.
Reg #: 3013271380
·
FEI: 3013271380
·
Expires 2026
Products
6
Proprietary Names
99
Establishment Types
1
Classifications
6
Registration Details
- Registration Name
- SEWON MEDIX, INC.
- Registration Number
- 3013271380
- FEI Number
- 3013271380
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- #29, Sasang-ro, 375 beon-gil, Sasang-gu
- City
- Busan
- Country
- KR
Regulatory Submissions
- 510(k) Number
- K153521
Owner / Operator
- Firm Name
- Sewon Medix, Inc.
- Operator Number
- 10053110
- Address
- #29, Sasang-ro, 375 beon-gil, Sasang-gu
- City
- Busan
- State
- KR-26
- Postal Code
- 46946
- Country
- KR
- Correspondent
- Jinsoo Lee
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gauge, Depth, Instrument, Dental | EIL | Class 1 | Dental | No | 2016-11-08 |
| Accessories, Implant, Dental, Endosseous | NDP | Class 1 | Dental | No | 2016-11-08 |
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2016-11-08 |
| Implant, Endosseous, Root-Form | DZE | Class 2 | Dental | No | 2016-11-01 |
| Abutment, Implant, Dental, Endosseous | NHA | Class 2 | Dental | No | 2016-11-01 |
| Applicator, Resin | KXR | Class 1 | Dental | No | 2022-07-05 |
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
BIOTHREAD BT3 Implant System
Plastic Coping (CPC450B, CPC450S)
Establishment Types
Manufacture Medical Device