Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006948193

FEI Number

3006948193

Entity Name

Shinhung MST Co., Ltd.

City/State/Country

Wonju Si Gangwon, KR

Establishment Address

110-2, Donghwagongdan-Ro, Munmak-eup, Wonju Si Gangwon 26365, KR

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SHINHUNG MST CO., LTD. (Owner Number: 10024874)

Owner / Operator Contact Address

110-2, Donghwagongdan-Ro, Munmak-Eup, Wonju Si, KR-42 26365, KR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DS40 SIDR20 ST32 SIDR2804 SIST08 SIST05 SHMLL SIST03 SKRP42 SIST11 SKRP32 SIDR27 SIST12 SKBC00 SKDG00 SHSC SKBP00 SKRP37 SIDR2803 SIST07 SHSC2 SHMLS SSGK SSCA00 SIST04 SIDR42 SIST02 SIST10 SIDR2802 SIDR32 SITD7503 SIDR37 SIST09 SIST06 SHSC3 SHSC1 DS50 HFD00NS SMH01 HGS57 STHFD01L TWSLA00 STWHS00L SMH00 TWBAA01 SFD360S DG00 H09D02S TP40W SCSD450 RTS00 TP35 STTWFA01L TWHA00ES H09D01L TWHA00S FMM ETWDW00 STTWFA01S ADH10 SFD420S TWFA00RL BCD18 NMDM SISK ASS DE10 TWFA00NS SCBD500 DI4L HFD01NEL SMA00L SCBD400 SFD315S SHS01L SFD385S SFD330S SFD370S SFD250S TWFA00NL SCSD400 ETWDR00 FMR OST270 TP45 SHS00L HFD00REL HGS50 STS00 TW00 SD100 SCSD330 SFD330L SFD435S H09D00L HFD00NL TWFA01RS ETWDN00 TWFA00RS SFD300L SFD485S OST330 GS50 STHFD01S SHS01ES FDRH STWHS00S HFD00RL TWFA01NL SMA00 SGK UDH25L UDS00S RKARN SFD485L TWFA01RL TWFA01NEL OST410 BCD14 GS57 SMA02S SHS02S TP50W HFD01NS SHHS00ES GG00 EHPDR00 RKARR NMDR H09TWD00L TWMA01L TWFA01NS SCBD450 SFD345L SRK00 SFD440L SPD300 SFD420L SCBD330 DI5S STWR00 HFD01NL FDMH H09D00S SFD360L DI5L HFD00RS SHS01S H09TWD00S TWBAA00 TWMA00L STWA00 DI00S SFD470L SFD345S SFD440S SCSD375 TWMA00S SFD300S STHFD01EL SHHS00S SMA00ES STTWFA01EL TWFA00NEL SFD250L STSAA01S FDWH SMA01L SGD180 SFD435L SFD370L NMDW FMW RKLNGN EHPDN00 DI00L ASL STSAA01L SFD315L SFD385L SDGR00 SFD470S EHPDW00 SDE00 TWHA00L SCSD500 H09HD00 SSGR50C RKSRT SHHS00L DI4S SCBD375 SHW00 UDS00L RKSTG TWA00 STRK40 TWMA00ES SMA01S TWFA00REL HFD00NEL UDH20L RKSLGR RKGH00 UDH20S STDK RKMIG RKSLGN UTWR00 UDU00S UDU00L RKLNGR TWSA00 SSGR57C UDH25S TWMA02L UPK00 SSGW50C / Sleeve for S-Guide SISK03U FWFA02RL FWFA02RS STTWFA02S FWFA02NS DP00S EDS00S GFDTWN FWFA02NL GMDTW GTP35 EVERKC RW00 EGK GFDTWR SDK EGKC GFDHR GMDH EVERK GFDHN SSPAC40 SSPAA4555 STAR4520HP SSPAA6055 SBCN5043H STBCR5031C SBCN5044H SSPAA4040 SAT40H EBCW5064H STBCSW31 SPP40 EBCN5066H SSPAA4070 SFPUR50HL SBCSR64 SFPUR50L SPP55 SFTN40HL SFTR60HS EBCN5064H SPUSR00L SAPU55 SFTR40S SFPUR50HS STBCR5042C SSPICC4555 SBCR5042H SAPU40H SAA55 STAR5030P SFPUN40S SPP55H STAN4030P SSPBC45B SSPAA4055 EBCSR44 SFTR40HS SFPUR50S SBCR5066H SBCSN44 SSPBC50B STAR4520P STBCR5062C STBCSW42 SBCN5042H TTBCR5062C ZTBC56064H SFTR60L SFTR50HS SBCSR66 SSPBC50S SSPAA4570 SFTSR00S SSPBC40S SFPUR60HL EBCSN42 SAT45H EBCN5044H EBCSN64 SBCSN66 STBCR5041C SAT45 TBBCR5042R SAPUS18 EBCSW66 ZTBC45064H TBBCR5066R SSPICC4055 SFAN35 TBBCS4042R SBCR6045H ZTBC56044H ZTBC35066H TTBCSN41 TBBCSS42 EBCSN44 SFPUN40HL STAR4510HP TBBCSS43 ZTBC56045H TTBCR5031C SSPBC60S EBCN5042H SSPAA5040 SFPUN40L SSPAA4540 ZTBC35044H SPP45 STBCSR62 SAPU55H SBCSR43 STBCSR41 SFTR40L SFTN40S SFTN40L SBCSN43 SFPUR40S ZTBC56043H TBBCSR64 ZTBCS43 ZTBC56066H SBCSR42 SSPICC5055 SAPU45H SSPBC40B SFTSR00L SAA40 SFPUN40HS STBCW6041C SAT40 EBCR5042H SFAR40 EBCSW44 SSPBC45S SPUSN00S STC55SP TTBCR5042C TBBCN5064R TTBCN5041R EBCR5044H SSPBC60B ZTBCS65 SFTR40HL SBCR5043H TBBCSR66 TBBCS4044R SBCSR45 SBCR6064H STBCSR42 SSPAA6070 SBCN5064H STAR5030HP SSPAC45 SAT55 EBCSR66 STAR5020P SAPU45 STAN4010HP SFTR50S EBCR5066H SAPU40 SBCSN42 SFTSN00S STBCSR31 SSPICC6055 SFTR50L SSPAC50 SSPAC60 SFPUR40L EBCW5042H EBCSW42 EBCSR64 SFPUR40HL SPUSR00S SBCR5044H STC45BP STC45SP TBBCS4043R SBCN5066H EBCW5044H STC55BP SBCR5064H ZTBC56042H TBBCSR45 SBCSR65 STAR4530HP SPP40H BAA45 EBCSR42 EBCSW64 STAN4010P STAN4030HP SAA45 SSPAA6040 SAT55H TBBCR5043R ZTBC35064H ZTBCS44 SATS18 SFTR60HL TBBCS4064R STBCW6062C TTBCN5031R EBCSN66 TTBCSN31 TTBCW6641C TBBCR5064R SFTR50HL SBCSR44 SSPAA5070 SFPUR60L SBCSN64 EBCW5066H SFTR60S STAR4530P STBCW6031C SFTN40HS TBBCN5042R ZTBC45042H TTBCSN42 ZTBCS66 TTBCW6662C STAR5020HP STBCSW41 SFPUR40HS ZTBC35043H TTBCR5041C TBBCSR65 ZTBC56065H ZTBC45065H TBBCN5066R SSPAA5055 SFPUR60HS SPP45H STBCW6042C TTBCN5042R TTBCW6642C ZTBCS64 TBBCSS66 TBBCN5043R ZTBC45066H SBCR5045H SBCR6065H STAR4510P EBCR5064H SPUSN00L SFTSN00L SFPUR60S TBBCSR44 TTBCSN62 TBBCR5045R ZTBCS45 TBBCN5044R TBBCR5065R TBBCSS64 SBCR6043H ZTBCS42 ZTBC45045H TTBCW6631C TBBCSR43 SBCR6044H ZTBC45044H TBBCS4066R TBBCR5044R TBBCSS44 TBBCSR42 SBCR5065H SBCR6066H ZTBC45043H ZTBC35042H TTBCN5062R SI BAT00 SPICC55 SPICC45 SPICC40 SPICC65 MagDen Implant System SSG53C SPBC45S SPBC65B SPBC65S SPBC55S SPBC45B SPBC40B PBC40S MRTN MRTR SSG53P

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EMJ	Elevator, Surgical, Dental	Dental	Class 1	872.4565	2013-11-20
EJB	Handle, Instrument, Dental	Dental	Class 1	872.4565	2008-05-23
EGG	Attachment, Precision, All	Dental	Class 1	872.3165	2008-05-23
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2013-11-18
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2013-11-18
EHY	Tray, Impression, Preformed	Dental	Class 1	872.6880	2008-05-23
DZE	Implant, Endosseous, Root-Form	Dental	Class 2	872.3640	2020-06-25
NHA	Abutment, Implant, Dental, Endosseous	Dental	Class 2	872.3630	2020-06-25
NDP	Accessories, Implant, Dental, Endosseous	Dental	Class 1	872.3980	2008-05-23

Official Correspondent

Mooncheol Gil

US Agent Details

Priscilla Chung Business: LK Consulting Group USA, Inc. Email: juhee.c@lkconsultinggroup.com Phone: (714) 9225276

Related Public Records

Same Entity

SHINHUNG MST CO., LTD.

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-0010-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect simply RePlant Implant, size 4.3mmD x 13mmL, 4.3mmD Platform, REF 604313U, Rx, Sterile. The firm name on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA.
Z-0017-2026	S.I.N. Implant System Ltda Rua Soldador Ocimar Guimaraes da Silva 421 Jardim Analia Franco Sao Paulo Brazil	2	IMPLANT EPIKUT PLUS MT16 3,5X10,0MM, REF: ILM 3510N; IMPLANT EPIKUT PLUS MT16 3.8X11.5MM, REF: ILM 3511N; IMPLANT EPIKUT PLUS MT16 3,5X13,0MM, REF: ILM 3513N; IMPLANT EPIKUT PLUS MT16 3,5X15,0MM, REF: ILM 3515N; IMPLANT EPIKUT PLUS MT16 3,8X10,0MM, REF: ILM 3810N; IMPLANT CM16 3,8 X 11MM, REF: ILM 3811N; IMPLANT EPIKUT PLUS MT16 3,8X15,0MM, REF: ILM 3815N; IMPLANT EPIKUT PLUS MT16 4,0X10,0MM, REF: ILM 4010N; IMPLANT EPIKUT PLUS MT16 4,0X11,5MM, REF: ILM 4011N; IMPLANT EPIKUT PLUS MT16 4,0X13,0MM, REF: ILM 4013N; IMP EPIKUT PLUS LONG MT16 4,0X20,0MM, RES: ILM 4020N; IMPLANT EPIKUT PLUS MT16 4,0X8,5MM, RES: ILM 4085N; IMPLANT EPIKUT PLUS MT16 4,5X13,0MM, REF: ILM 4513N; IMPLANT EPIKUT PLUS MT16 4,5X15,0MM, REF: ILM 4515N; IMPLANT EPIKUT PLUS MT16 4,5X8,5MM, REF: ILM 4585N; IMPLANT EPIKUT PLUS MT16 5,0X10,0MM, REF: ILM 5010N; IMPLANT EPIKUT PLUS MT16 5,0X11,5MM, REF: ILM 5011N; IMPLANT EPIKUT PLUS MT16 4,5X10,0MM, REF: ILM 4510N; IMPLANT EPIKUT PLUS MT16 5,0X13,0MM, RES: ILM 5013N; IMPLANT EPIKUT PLUS MT16 5,0X15,0MM, REF: ILM 5015N; IMPLANT EPIKUT PLUS MT16 5,0X8,5MM, REF: ILM 5085N; IMP EPIKUT PLUS LONG MT16 4,0X18,0MM, REF: ILM 4018N; IMP EPIKUT PLUS LONG MT16 3,8X18,0MM, REF: ILM 3818N; IMPLANT EPIKUT PLUS MT16 4,5X11,5MM, REF: ILM 4511N; IMPLANT EPIKUT MT16 4,5X15,0MM, REF: ILM 4515; IMPLANT EPIKUT MT16 4,5X8,5MM, REF: ILM 4585; IMPLANT EPIKUT MT16 3,8X13,0MM, REF: ILM 3813; IMPLANT EPIKUT MT16 3,8X15,0MM, REF: ILM 3815; IMPLANT EPIKUT MT16 5,0X8,5MM, REF: ILM 5085; IMPLANT EPIKUT MT16 3,8X11,5MM, REF: ILM 3811; IMPLANT EPIKUT PLUS MT16 3,8X20,0MM, REF: ILM 3820N; IMPLANT EPIKUT PLUS MT16 4,5X18,0MM, REF: ILM 4518N; IMPLANT UNITITE MORSE COMPACT 6.0X7MM, REF: UCMC 6007N
Z-0018-2020	Implant Direct Sybron Manufacturing, LLC	2	ImplantDirect Legacy 3 Implant, REF 855216, SBM implant assembly, 2mmD x 16mmL, 4.5mmD platform, Rx, Sterile. The mislabeled model/part number on the vial cap is 835216. The responsible firm on the label is Implant Direct Sybron Manufacturing LLC, Thousand Oaks, CA. - Product Usage:Implant Direct Sybron Manufacturing LLC s dental implant product line consists of one-piece and two-piece implants for one-stage or two-stage surgical procedures. These implants are intended for use in partially and fully edentulous upper and lower jaws in support of single or multiple-unit restorations and terminal or intermediate abutment support for fixed bridgework.
Z-0019-2020	Paltop Advanced Dental Solutions Ltd 5, Ha-Shita Caesarea Israel	2	Paltop Advanced Plus Dental Implant Dia 6.0mm L10mm Catalog Number: 20-70024P
Z-0029-05	Implant Innovations, Inc.	2	EP Healing Abutment- An abutment device is a premanufactured prosthetic component directly connected to the endosseous dental implant.

Similar Registrations

Registration Number	Establishment Name	Location
1032227	BRASSELER U.S.A. DENTAL, LLC	SAVANNAH, GA, US
3004215117	MILLENNIUM SURGICAL CORP	Schaumburg, IL, US
1836161	ASPEN SURGICAL PRODUCTS, INC.	Caledonia, MI, US
8040278	Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, PK
9681540	ULTRA SURGICAL (PVT.) LTD	SIALKOT Punjab, PK

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006948193. Last updated year: 2026. Please use registration number 3006948193 when referencing this establishment in official correspondence.