Manufacturer registered with FDA
Osung Mnd Co Ltd
Gimpo-si, South Korea. Lists 58 dental device types with FDA across 1 registered establishment.
- Device types listed
- 58
- Brands and models
- 1,644
- 510(k) clearances
- 0as applicant
- Markets registered in
- 857 registrations outside the US
- Establishments
- 1South Korea
Registered in 8 markets
Where regulators' registries name Osung Mnd Co Ltd as the manufacturer or the registration holder of a device.
RegisteredHome: South KoreaOne marker per market
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | Osung Mnd Co Ltd | 58 device types | — | Below |
| Australia | TGA | Manufacturer | Osung Mnd Co Ltd | 23 | 2017–2019 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | OSUNG MND CO., LTDOSUNG MND CO., LTD. | 13 | 2007–2021 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | OSUNG MND CO., LTD. | 11 | 2013–2025 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | Osung MND CO, LTD | 7 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | OSUNG MND CO.LTD. | 1 | 2020–2020 | Pure Global AI |
| China | NMPA | Registration holder | 五星医疗器械有限公司OSUNG MND CO., LTD. | 1 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | OSUNG MND CO., LTD. | 1 | — | 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 Osung Mnd Co Ltd currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | Bone tack (BTKIT) | 2015 |
| Intraoral Dental DrillDZA · Class 1 | Surgical drills & motors | Maker | BEPDP13BSWDR1BSWDR1.3BSWDR1.6LLL21LLL26LLS21LLS26 | 2007 |
| Dental Diamond InstrumentDZP · Class 1 | Dental burs & diamonds | Maker | DBGLKDBGOKDBINKDBMEKDBZIKLABEC62NBRBEC50RSBTRMZR137.14M1ZR194.16M4 591 more001 801 009001 801 018001.12M1001.14M1001.16M1001.18M1001.19C1001.19C2001.25EC1001.25M1001.29C1001.29C2001.30EC1001.30M1001.8M1001.9M1001ABR-019C001ABR-029C001ABR-S019C001ABR-S029C001BR-31001BR-40001BR-41001BR-46001BR-49019DI-41019DI-42032.10M1032.14M1032.15M1033.14EF1033.14F1037.33M1037.35F1037.35M1037.35M2038 811 033039ATP-035039EX-12039EX-12F068.42C1068.42M1068WR-13068WR-13C107.10C4107.10M1107.10M2107.10M3107.12M1107.13M1107.14M1107.14M2107.14M3107.8F1107.8M2108CD-58F108JSF-008108JSF-010109JSF-010109SF-31109SF-41110SF-21111 837 014111SF-11111SF-12126.12M1126.12M2129 884 012130 885 012137.10M1137.12M1137.14EC1137.14F1137.14M1137.16EC1137.16F1137.16M1137.18EC1137.18F1137.18M1137.20EC1137.20F1137.20M1137.9M1141SR-11141SR-12141SR-13141SR-13C141SR-13EF141SR-13F147SRP-018150.10F1150.10M1150EX-18F156 835KR 010156 835KR 016156.10M1156.12M1156.16M1157 836KR 012159.10EF1159.10F1159.15EF1159.15F1159.25EF1159.25F1160ACN-016C160APC-014160APC-014F160APC-016160APC-016F160TC-11160TC-11C160TC-11EF160TC-11F160TC-21160TC-21EF160TC-21F160TC-26160TC-S21161AFN-010EF161AFN-010F162AOB-015EF162AOB-015F162AOB-025EF162AOB-025F164.10EF2164.10EF4164.10F2164.10F3164.10F4164.10M1164.10M2164.10M4164.12EC2164.12F2164.12M1164.12M2164.14EC1164.14EF2 | 2014 |
| Mouth MirrorEAX · Class 1 | Dental hand instruments | Maker | BDMHLBDMHLTBDMHMBDMHSDMAPADMBFLDMBFLTDMBFMDMBFSDMCS3 29 moreDMCS4DMCS5DMDCS4DMDSS4DME1DME1GDME2DME2GDME3DME3GDME4DME4GDME5DME5GDME6GDMEMDMFCS4DMFCS5DMFEMDMFPMDMFSS4DMFSS5DMPMDMPRADMPRPDMS39DMSS3DMSS4DMSS5 | 2007 |
| Retentive and Splinting Pin and Accessory InstrumentsEBL · Class 1 | — | Maker | ORCRLORCRM | 2007 |
| Suction Operatory UnitEBR · Class 1 | Suction & evacuation units | Maker | SN3STSSN3STSLSN3TISN4STSSN4TISNF123SNF137SNF178SNF190SNF20 9 moreSNF25SNF2DSNF30SNF3D1SNF3D2SNFOKITSNK20KSNK25KSNK30K | 2008 |
| Air and/or Water Syringe UnitECB · Class 1 | Dental hand instruments | Maker | SAE-01 | 2007 |
| Orthodontic Ligature Tucking InstrumentECP · Class 1 | Dental hand instruments | Maker | ORWB1ORWB3ORWB4 | 2009 |
| Orthodontic Band PusherECS · Class 1 | Dental hand instruments | Maker | 3ORWBP1 | 2016 |
| Rubber Dam ClampEEF · Class 1 | Rubber dam systems | Maker | RDC2RDC201RDC202RDC203RDC204RDC207RDC210RDC211RDC2ARDCSET 2 moreRDSETRDSTD2 | 2012 |
| Articulation Paper ForcepsEFK · Class 1 | Dental hand instruments | Maker | PHNS | 2012 |
| Dental Dressing ForcepsEFL · Class 1 | Dental hand instruments | Maker | EAPCUL155MF01ORT160PC1PCU155PCUL155PCW150PT41PT42PT52C 3 morePTB19PTG1PTS22C | 2007 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | SCC105SCD170SCGC130SCGS130SCLC115SCLSA115SCLSS115SCMB130SCMB145SCT115 1 moreSCTC115 | 2007 |
| Polishing Agent StripEHM · Class 1 | Polishing & prophylaxis | Maker | SRTD15SRTD15HSRTD25SRTD25HSRTD40SRTD40HSRTD5PSRTD60SRTD60HSRTD90 15 moreSRTD90HSRTDH5PSRTSD15SRTSD40SRTVD15SRTVD15HSRTVD25SRTVD25HSRTVD40SRTVD40HSRTVD60SRTVD60HSRTVD90SRTVD90H3PSTARTER | 2017 |
| Preformed Impression TrayEHY · Class 1 | Impression trays | Maker | TARLLTARLUTARMLTARMUTARP1TARP2TARPATARPBTARSLTARSU 45 moreTARZ10TBELLTBELUTBEMLTBEMUTBESLTBESUTBEXLLTBEXLUTBEZ8TBOLLTBOLUTBOMLTBOMUTBOSLTBOSUTBOZ6TBWLLTBWLUTBWMLTBWMUTBWP1TBWP2TBWP3TBWP4TBWPATBWPBTBWPZ4TBWPZ6TBWSLTBWSUTBWXLLTBWXLUTBWZ6TSELLTSELUTSEMLTSEMUTSESLTSESUTSEXLLTSEXLUTSEZ8TXAROTXASP | 2007 |
| Oral Cavity EvacuatorEHZ · Class 1 | Suction & evacuation units | Maker | SN3SUSSN3SUSLSN3TISN4SUSSN4TISNC45SNF20SNF25SNF30SNKCS 2 moreSNKHSSNR40 | 2017 |
| Rubber DamEIE · Class 1 | Rubber dam systems | Maker | DA614BPDA614GMDA618BPDA618GMDA622BPDA622GMO-DA614BPO-DA614GMO-DA618BPO-DA618GM 2 moreO-DA622BPO-DA622GM | 2012 |
| All Types RetractorEIG · Class 1 | Dental hand instruments | Maker | GRM1GRM2GRM3RTAN20RTCN10RTCN8RTCPD1RTCPD2RTCPD3RTCPS1 18 moreRTCPS2RTCRCRTCRLRTCRMRTLASRTLSRTLW6540RTLW7045RTLW8050RTP30RTP90-1RTSWSHRTSWSMRTSWSSRTTG3GRM13GRM23GRM3 | 2007 |
| Dental Wax CarverEIK · Class 1 | Dental hand instruments | Maker | L-PKTLCPKT1LCPKT2LCPKT3LCPKT4LCPKT5 | 2007 |
| Dental Instrument Depth GaugeEIL · Class 1 | Dental hand instruments | Maker | DG1LPC90LPC90SOGBH018OGBH022OGPMPW16PW21WLG1 | 2007 |
| Crown RemoverEIS · Class 1 | Dental hand instruments | Maker | CF01CF02CFP5CFRT85CG01RECR3SKIT3RECDA3RECDB4RECDA4RECDB | 2007 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Maker | BPCP10BPCP11BPCP12BPCP12NBPCP2BPCP8BPGF-WBPQ2NBPUNC15BPW 42 moreBPW15BPWBBPWHOEXD11-12EXD17-23EXD2EXD3CHEXD54-17HEXD5HEXD5WEXDG16EXDKEXS23HEXS23WEXS3EXS3AEXS54HEXS6EXS6LEXS6XLEXS96XP23-11XP23-12XP23-12BXP23-8XP23-WXP23-W-WXP23-WHOXPG-12XPG-12B2BPCP122BPCP82BPUNC152EXD17-232EXD5-82EXD5H2EXD5W2EXDG163IBPCP123IBPCP23IBPCP2-123XP23-WHO | 2007 |
| Dental Plastic Filling InstrumentEIY · Class 1 | Dental hand instruments | Maker | CSAT6CSCOM1CSCOM11CSCOM13CSCOM2CSCOM3CSCOM4CSCOM5CSCOM6CSCOMKIT 45 moreCSCT1CSCT10CSCT15CSCT6CSCT7CSCT8CSF1WCSF2CSF3PF43-47PF48-702PFIW3PFWDS2PFWDS3PICHPIS2CSAT62CSCOM12CSCOM112CSCOM132CSCOM22CSCOM32CSCOM42CSCOM52CSCOM62CSCOMKIT2CSCT12CSCT102CSCT152CSCT62CSCT72CSCT83CSCOM113CSCOM133CSCT13CSCT153CSCT63CSCT83CSK013CSK023PF43-473PF48-7023PFIW33PFWDS23PFWDS3 | 2007 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | MHCMHSSH2SSHCSHSSRTHD2MHC12MHC22MHC32MHS1 | 2007 |
| Rubber Dam FrameEJE · Class 1 | Rubber dam systems | Maker | RDFR1RDFR2 | 2007 |
| Rubber Dam Clamp ForcepsEJG · Class 1 | Rubber dam systems | Maker | RDPL1 | 2014 |
| Cartridge SyringeEJI · Class 2 | Dental needles & syringes | Maker | GMIJ43GMIJ48SAA1SAB1SAC1SAE1SAF1SBA18SBA18T1SBA18T2 1 moreSBA18T3 | 2008 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | BL012C4BL012EF2BL012EF4BL012EF6BM012EF2BXL014EF6CIS012CIS013FCIS016CISS013 78 moreCISS016CRP019EFCRP019SFDCL010EFDCL010FDCL012EFDCL012FDCL014CDCL014EFDCL014FDCL016FDCM009FDCM010CDCM010EFDCM010FDCM012EFDCM012FDCM014DCM014CDCM014EFDCM014FDCM016CDCM016FDCXL014FDCXL016FDCXL018FDCXXL014FFBL014EFFBL019FBL019EFFBL019SFFBL023FBL025FBL025FFBM014EFFSM010FSM010FFSS009CFSS009FGRL020GRM020CIM008FIM011FIS008FIS011FIS013FND010ND010FPSM019CPSM019FRP015EFRP015SFTCL009FTCL011TCL013CTCL013FTCM009FTCM011TCM013FTCM015FTHB30THB40THB50THB60THB70THB80THB90THR50THR60TRL010TRL010FTRL012FTRL014FTRM010TRM014TRXL010CTRXL012FTRXL014F | 2009 |
| ArticulatorsEJP · Class 1 | Articulators & facebows | Maker | ACBA1 | 2007 |
| Operative PliersEJY · Class 1 | Dental hand instruments | Maker | CPTC135RCA197RCP200 | 2007 |
| Operative Margin Finishing KnifeEJZ · Class 1 | Dental hand instruments | Maker | MT26MT27MT28MT29 | 2007 |
| Operative Margin Finishing FileEKA · Class 1 | Dental hand instruments | Maker | FSH3-7FSH5-11PDS1-2SPDS3-4SPDS9-10S | 2007 |
| Operative ExplorerEKB · Class 1 | Dental hand instruments | Maker | e-EXD5HEXD11-12EXD17-23EXD2EXD23H-7HEXD3-3AEXD3-9HEXD3CHEXD5-8EXD54-17H 38 moreEXD5HEXD5WEXDG16EXDKEXDPR05EXDPR058EXS17WEXS23HEXS23WEXS3EXS3AEXS3AHEXS3HEXS54HEXS6EXS6LEXS6XLEXS96EXS9HEXSPR01EXSTU17H2EXD17-232EXD23H-7H2EXD3-3A2EXD3-9H2EXD5-82EXD54-17H2EXD5H2EXD5W2EXDG162EXS17W2EXS3AH2EXS3H2EXS54H2EXS962EXS9H2EXSFM2EXSTU17H | 2007 |
| Operative Dental ExcavatorEKC · Class 1 | Dental hand instruments | Maker | EXC17EXC18EXC31LEXC32LEXC33LEXC38-39EXC63-64EXC65-66EXCE1EXCE2 14 moreEXCL61-62EXCL63-64EXCL65-663EXC173EXC183EXC31L3EXC32L3EXC33L3EXC38-393EXC63-643EXC65-663EXCL61-623EXCL63-643EXCL65-66 | 2007 |
| Operative Cutting InstrumentEKD · Class 1 | Dental hand instruments | Maker | TNC100TNC165 | 2014 |
| Operative Amalgam and Foil CondenserEKG · Class 1 | Dental hand instruments | Maker | GCP113GCP113NGCP170GCP171GCPS6PLG0-1PLG1-2PLGOR1PLGOR3 | 2009 |
| Operative Dental Amalgam CarverEKH · Class 1 | Dental hand instruments | Maker | CV3CV3SCV74-75CV76-77CVCD3-6CVCD89-92 | 2007 |
| Operative Amalgam CarrierEKI · Class 1 | Dental hand instruments | Maker | PLGWL1PM1520PM2025PM2030 | 2009 |
| Operative BurnisherEKJ · Class 1 | Dental hand instruments | Maker | BB26-27SBB27-29BB31-32BBL3 | 2007 |
| Endodontic Pulp Canal Filling Material SpreaderEKK · Class 1 | Dental hand instruments | Maker | SR1SSRMA57 | 2007 |
| Endodontic Root Canal PluggerEKR · Class 1 | Dental hand instruments | Maker | RCP1-3RCP10RCP11RCP5-7RCP9RCP9-11RCPGL1 | 2007 |
| Surgical HemostatEMD · Class 1 | Dental hand instruments | Maker | BOS-SIKHTK145HTK145CHTM120CHTM130HTM130CNH150TC-PNH160NH160TCNH160TC-P 2 moreNHC130TCNHC150TC | 2007 |
| Surgical Biopsy PunchEME · Class 1 | Dental hand instruments | Maker | RDPN1RDPN1PTP35TP40TP40CJTP45TP50TP50CJTPH35CTPH35S 10 moreTPH40CTPH40STPH45CTPH45STPH50CTPH50STPI40TPI40GTPI50TPI50G | 2007 |
| Surgical Tooth Extractor ForcepsEMG · Class 1 | Dental hand instruments | Maker | FX1FX101FX10SFX150FX150SFX151FX151SFX17FX222FX300 16 moreFX301FX53LFX53RFXX13FXX13CFXX17FXX18FXX2FXX22FXX29CFXX33CFXX51CFXX67AFXX7FXX79FXX7C | 2007 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | RNG165RNG178RNGF140RNGSK100 | 2007 |
| Surgical Bone FileEMI · Class 1 | Dental hand instruments | Maker | BF1XBF22BF45 | 2007 |
| Dental Surgical ElevatorEMJ · Class 1 | Dental hand instruments | Maker | EL301EL301AEL304WEL31FEL32FEL34EL34SEL4EL41EL5 115 moreEL52EL73EL74EL81EP14EP15EP16EP20EP23EP24GEP9EP9HEP9SEPBUSEREPKN1EPPR3ERHB13-14ERP1ERP2ERP3IS6577SC5IS65785ISPKN152ISSC1ISSC2ISSL1ISSL2ISSL3ISSL4ISSLKITMXP3CMXP3SMXP3SCMXP6CMXP6SMXP6SCMXP75SMXP9CMXP9SMXP9SCMXS13EL3013EL301A3EL304W3EL31F3EL32F3EL343EL34S3EL43EL413EL53EL523EL733EL743EL813ELL3013ELL3023ELL3033ELL30K3ELL5013ELL5023ELL5033ELL50K3ELLD5013ELLD5023ELLD5033ELLD50K3ELLR3013ELLR3023ELLR3033ELLR30K3ELLR5013ELLR5023ELLR5033ELLR50K3ERP13ERP23ERP34EL3014EL301A4EL304W4EL31F4EL32F4EL344EL34S4EL44EL414EL54EL524EL734EL744EL814ELL3014ELL3024ELL3034ELL30K4ELL5014ELL5024ELL5034ELL50K4ELLD5014ELLD5024ELLD5034ELLD50K4ELLR3014ELLR3024ELLR3034ELLR30K4ELLR5014ELLR5024ELLR5034ELLR50K4ERP14ERP24ERP3 | 2007 |
| Dental Surgical CuretteEMK · Class 1 | Dental hand instruments | Maker | URCL84URCL85URCL85MDURCL86URCL87URCL88URCM10URCM11URCM2-4URCM9 4 moreURPR1-23URCL85C3URCL86C3URCL87C | 2007 |
| Surgical Bone ChiselEML · Class 1 | Dental hand instruments | Maker | CHBC1CHC13K-TGCHC36-37CHCO1CHCO2CHCP3-4CHS13K-13KLMXSP6MXSP9 | 2007 |
| Surgical Osteotome ChiselEMM · Class 1 | Dental hand instruments | Maker | BOC22BOC28BOC35BOC35RBOCV20FBOCV28FBOCV33FBOCV38FBOCV43FBOCV50F 5 moreBOVX28FBOVX33FBOVX38FBOVX43FBOVX50F | 2007 |
| Periodontic ScalerEMN · Class 1 | Dental hand instruments | Maker | CGR1-2CGR11-12CGR13-14CGR15-16CGR17-18CGR3-4CGR5-6CGR7-8CGR9-10CMGR1-2 91 moreCMGR11-12CMGR13-14CMGR3-4CMGR5-6CMGR7-8CMGR9-10CRGR1-2CRGR11-12CRGR13-14CRGR3-4CRGR5-6CRGR7-8CRGR9-10CSZDiagnostic&Supragingival ScalingHSA12-13HSL34-35HSO8-9HSP56-57ICGR1-2ICGR11-12ICGR13-14ICGR5-6ICGR7-8LS204LS204SLS204SDLSH5-33LSH6-H7LSJAC30-33LSJAC31-32LSJAC34-35LSMS1-2LSMS11-12LSSCM152LSU15-30LSU15-33USEAUSEPUSEPSUSS12CGR1-22CGR11-122CGR13-142CGR15-162CGR17-182CGR3-42CGR5-62CGR7-82CGR9-102CLGR1-22CLGR11-122CLGR13-142CLGR3-42CLGR5-62CLGR7-82CLGR9-102CMGR1-22CMGR11-122CMGR13-142CMGR3-42CMGR5-62CMGR7-82CMGR9-102LSH5-332LSH6-H72LSJAC30-332LSJAC31-322LSJAC34-352LSMS1-22LSMS11-123CGR1-23CGR11-123CGR13-143CGR15-163CGR17-183CGR3-43CGR5-63CGR7-83CGR9-103CRGR1-23CRGR11-123CRGR13-143CRGR3-43CRGR5-63CRGR7-83CRGR9-103LSJAC34-353LSK013LSK023LSU15-33 | 2007 |
| Periodontic KnifeEMO · Class 1 | Dental hand instruments | Maker | KNK15-16KNO1-2PR2-2RPRM1PRR256PRR258PRRS3PRTUTITU1TITU2 5 moreTITU3TITU4TITU5TITU6TNC100 | 2007 |
| Periodontic MarkerEMP · Class 1 | Dental hand instruments | Maker | OGBH018OGBH022OGPAOGPPSM-01SM01SMGC100SMGC70SMGC80SMGC90 | 2012 |
| Periodontic CuretteEMS · Class 1 | Dental hand instruments | Maker | CGR11-14CGR12-13CU2L-2RCU4L-4RCUC13-14CUGF3CUMC13S-14SCUSUB-0CUSYN15-16CUSYN15-16M 7 moreCUYG7-82CU2L-2R2CUC13-142CUGF32CUMC13S-14S2CUSYN15-162CUSYN15-16M | 2007 |
| Gingival Fluid MeasurerJEO · Class 1 | — | Maker | LPC170LPC90 | 2012 |
| Orthodontic PlierJEX · Class 1 | Dental hand instruments | Maker | BOS-OPKOPAP01OPAP02OPAP03OPAP04OPBI01OPBI02OPBI03OPBR01OPCB01 19 moreOPDE01OPDE02OPLF01OPLM01OPPC01OPPC02OPPC03OPSP02OPUP01OPWB01OPWB02OPWB03OPWB04OPWB05OPWB06OPWB07OPWB08OPWB09OPWB10 | 2016 |
| Tongue ScraperLCN · Class 1 | — | Maker | ITA-01NTTS1 | 2007 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | ARP1ARR1BEPDBEPD2BSC3539BSWDTLBSWDTSBSY35BSY47BSY70 23 moreBTIDH09BTSHCBTSHCOBWSUS1DBKC-ADBKC-BDSTA16GP2530GP3340IDH5-15NIDH7-15NOCAKITOLAKITRGCP1RGCPDRSC30S24-325S26-325S26-345S30-345S35-395USETWUSSTA5 | 2007 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Osung Mnd Co Ltd lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Miles Laboratories, Inc. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 16 Jul 1984 | K842006 | CITOJECT CARTRIDGE SYRINGE | Miles Laboratories, Inc. | EJI Cartridge Syringe |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| OSUNG MND CO., LTD.FDA reg. 9616119 | Gimpo-si Gyeonggi, South Korea | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10023032). 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.