FDA Registration
Active
🇰🇷 South Korea
Drill & Drill Accessories (Guide Drill, Drill Extension, Twist Drill, Pilot Drill, Cortical Drill, Drill Stopper)
Reg #: 3013271380
·
FEI: 3013271380
·
Expires 2025
Products
1
Proprietary Names
44
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- SEWON MEDIX, INC.
- Registration Number
- 3013271380
- FEI Number
- 3013271380
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- #29, Sasang-ro, 375 beon-gil, Sasang-gu
- City
- Busan
- Country
- KR
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 |
|---|---|---|---|---|---|
| Drill, Dental, Intraoral | DZA | Class 1 | Dental | No | 2016-11-08 |
Proprietary Names
Drill & Drill Accessories (Guide Drill, Drill Extension, Twist Drill, Pilot Drill, Cortical Drill, Drill Stopper)
STOPPER DRILL KIT(DKT, DKP, DKE, SDK)
EXTRA DRILL FOR STOPPER(EAS3015S, EAS3315S, EAS3815S, EAS4315S, EAS5315S)
Drill & Drill Accessories (Sidecut Drill, Bone Profiler, Trephine Drill)
EXTRA DRILL(EA5307, EA5308, EA5310, EA5311, EA5313, FD5513, FD5013)
PILOT DRILL(SPD30, SPD33, SPD38, SPD43)
STRAIGHT DRILL(ST4307, ST4308, ST4310, ST4311, ST4313, ST5307, ST5308, ST5310, ST5311, ST5313)
PROSTHETICS KIT-125(PK125S, PK125B, PK125SS, PK125BS)
STEP DRILL(SP223007, SP223008, SP223010, SP223011, SP223013, SP303307, SP303308, SP303310, SP303311, SP303313)
SURGICAL KIT(SFK, SSK)
EXTRA DRILL FOR STOPPER(EAS3015L, EAS3315L, EAS3815L, EAS4315L, EAS5315L)
GUIDE DRILL(SGD21), DRILL EXTENSION(SDE260)
EXTRA DRILL(EA3007, EA3008, EA3010, EA3011, EA3013, EA3307, EA3308, EA3310, EA3311, EA3313)
PROSTHETICS KIT-128(PK128S, PK128B, PK128SS, PK128BS)
TISSUE PUNCH(STP33, STP38, STP43, STP48, STP53, STP63)
SURGICAL TAP(IHFTM35, IHFTM37, IHFTM40, IHFTM45, IHFTM50, IHFTM60
SURGICAL KIT-K3(STK3B, STK3S, SEK3B, SEK3S, SPK3B, SPK3S)
STRAIGHT DRILL(ST3007, ST3008, ST3010, ST3011, ST3013, ST3307, ST3308, ST3310, ST3311, ST3313)
STRAIGHT DRILL(ST2207, ST2208, ST2210, ST2211, ST2213, ST2707, ST2708, ST2710, ST2711, ST2713)
STRAIGHT DRILL(ST3807, ST3808, ST3810, ST3811, ST3813)
EXTRA DRILL(EA3807, EA3808, EA3810, EA3811, EA3813, EA4307, EA4308, EA4310, EA4311, EA4313)
SURGICAL KIT-K7(STK7B, STK7S, SEK7B, SEK7S, SPK7B, SPK7S)
PROSTHETICS KIT-K5(PK5S, PK5B, SPK)
STEP DRILL(SP435307, SP435308, SP435310, SP435311, SP435313)
PROSTHETICS KIT-123(PK123S, PK123B, PK123BS)
STRAIGHT DRILL FOR STOPPER(, TS3D5317, STS2215, STS2715, STS3015, STS3315, STS3815, STS4315, STS5315)
STEP DRILL FOR STOPPER(SPS3843L, SPS4353S, SPS4353L)
STRAIGHT DRILL FOR STOPPER(TS2D2217, TS3D3017, TS3D3317, TS3D3817, TS3D4317)
SURGICAL TAP(IHFTR35, IHFTR37, IHFTR40, IHFTR45, IHFTR50, IHFTR60)
STEP DRILL(SP333807, SP333808, SP333810, SP333811, SP333813, SP384307, SP384308, SP384310, SP384311, SP384313)
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)
SEWONGUIDE INITIAL DRILL (SGST2207, SGST2208, SGST2210, SGST2211, SGST2213)
BONE TRIMMER (SBT50)
SEWONGUIDE EXTRA DRILL (SGEA3807, SGEA3808, SGEA3810, SGEA3811, SGEA3813)
SEWONGUIDE KIT (SGK5B)
EXPANDER DRILL (SEP274108, SEP274110, SEP274111, SEP314508, SEP314510, SEP314511)
EXPANDER DRILL (SEP162808, SEP162810, SEP162811, SEP223608, SEP223610, SEP223611)
SAW (SSAW70)
EXPANDER KIT (SEPK3B)
SEWONGUIDE EXTRA DRILL (SGEA4307, SGEA4308, SGEA4310, SGEA4311, SGEA4313)
SEWONGUIDE EXTRA DRILL (SGEA3007, SGEA3008, SGEA3010, SGEA3011, SGEA3013)
SEWONGUIDE EXTRA DRILL (SGEA3307, SGEA3308, SGEA3310, SGEA3311, SGEA3313)
Establishment Types
Manufacture Medical Device