Manufacturer registered with FDA
Biomaterials Korea, Inc.
Hanam-si, South Korea. Lists 17 dental device types with FDA across 1 registered establishment, and holds 5 510(k) clearances as applicant.
- Device types listed
- 17
- Brands and models
- 318
- 510(k) clearances
- 52007–2023
- Markets registered in
- 514 registrations outside the US
- Establishments
- 1South Korea
510(k) clearances per year, 2000–2026
Registered in 5 markets
Where regulators' registries name Biomaterials Korea, Inc. 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 | Biomaterials Korea, Inc. | 5 clearances | 2007–2023 | Below |
| Taiwan | TFDA | Manufacturer | BIOMATERIALS KOREA, INC.BioMaterials Korea, Inc. | 6 | 2010–2012 | Pure Global AI |
| Colombia | INVIMA | Manufacturer | BIOMATERIALS KOREA, INC. | 5 | — | Pure Global AI |
| Peru | DIGEMID | Manufacturer | BIOMATERIALS KOREA, INC. | 2 | 2022–2023 | Pure Global AI |
| Brazil | ANVISA | Manufacturer | BIOMATERIALS KOREA INC. | 1 | 2017–2017 | 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 Biomaterials Korea, 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 |
|---|---|---|---|---|
| Orthodontic Endosseous ImplantOAT · Class 2 | — | Maker | ACRAnchor PlateOAS-T1809-SPOAS-T1811-SPOAS-T1813-SP | 2007 |
| Orthodontic Screw Expansion RetainerDYJ · Class 1 | Retainers, expanders & headgear | Maker | KBE II-10KBE II-12KBE II-6KBE II-8KBE-10KBE-12KBE-6KBE-8MSE II-10 EMSE II-10 F 51 moreMSE II-10 GMSE II-10 HMSE II-12 EMSE II-12 FMSE II-12 GMSE II-12 HMSE II-6 EMSE II-6 FMSE II-6 GMSE II-6 HMSE II-8 EMSE II-8 FMSE II-8 GMSE II-8 HMSE III-10 AMSE III-10 BMSE III-12 AMSE III-12 BMSE III-6 AMSE III-6 BMSE III-8 AMSE III-8 BMSE IV-10 AMSE IV-10 BMSE IV-12 AMSE IV-12 BMSE IV-6 AMSE IV-6 BMSE IV-8 AMSE IV-8 BMSE-10MSE-11MSE-12MSE-6MSE-8RPE A-10RPE A-12RPE A-6RPE A-8RPE B-10RPE B-12RPE B-6RPE B-8RPE C-10RPE C-12RPE C-6RPE C-8RPE D-10RPE D-12RPE D-6RPE D-8 | 2005 |
| Orthodontic Material BandDYO · Class 1 | Orthodontic wires & bands | Maker | ACR | 2006 |
| Orthodontic WireDZC · Class 1 | Orthodontic wires & bands | Maker | ACR | 2006 |
| Orthodontic Wire ClampECN · Class 1 | — | Maker | DISCOpender 2.8DISCOpender 2.8XDISCOpender 4DISCOpender 468DISCOpender 6.5DISCOpender 6.5X | 2016 |
| Orthodontic SpringECO · Class 1 | Orthodontic wires & bands | Maker | NLT-LENLT-LESNLT9-EHNTH-LENTH-LESNTH-LHNTH-LHSNTH-LLNTH-LLSNTH12-EE 30 moreNTH12-EHNTH9-EENTH9-EHNTL-LHNTL-LHSNTL-LLNTL-LLSNTL12-EENTL12-EHNTL9-EENTM-LENTM-LESNTM-LHNTM-LHSNTM-LLNTM-LLSNTM12-EENTM12-EHNTM9-EENTM9-EHNTU-LENTU-LESNTU-LHNTU-LHSNTU-LLNTU-LLSNTU12-EENTU9-EENTU9-EHNYU12-EH | 2016 |
| Orthodontic Band DriverECT · Class 1 | Dental hand instruments | Lister | 4809 | 2014 |
| Dental Surgical Tissue ScissorsEGN · Class 1 | Dental hand instruments | Maker | ACR-PC18048154928496249956453663669377197 | 2014 |
| Periodontic ProbeEIX · Class 1 | Dental hand instruments | Lister | 430965846668 | 2014 |
| Dental Instrument HandleEJB · Class 1 | Dental hand instruments | Maker | MHD-SMSMHD-YMHD12MHD15MHDCMHDC-HPMHDORWSDH1SDH2 2 moreSDH3SDH4 | 2006 |
| Dental BurEJL · Class 1 | Dental burs & diamonds | Maker | OSD-1034-12COSD-1050-07SOSD-1062-06SOSD-1070-12SOSD-1070-14SOSD-11105-21SOSD-1150-15SOSD-12105-14SOSD-1228-09COSD-1231-12C 46 moreOSD-1265-07SOSD-1270-07SOSD-1270-09SOSD-1270-14SOSD-1325-11COSD-1370-14SOSD-1370-20SOSD-1415-05C (1.34mm)OSD-1434-04COSD-1450-07SOSD-1465-05SOSD-1465-07SOSD-1470-14SOSD-1470-14S (1.37mm)OSD-1470-26OSD-15115-11SOSD-1550-11SOSD-1550-20SOSD-1570-20SOSD-16105-14SOSD-16105-21SOSD-16105-23SOSD-16125-21SOSD-1620-07COSD-1622-09COSD-1625-12COSD-1633-14COSD-1650-07SOSD-1660-22SOSD-1662-06SOSD-1665-07SOSD-1670-05SOSD-1670-07SOSD-1670-09SOSD-1670-14SOSD-18105-07SOSD-18105-14SOSD-18105-25SOSD-1824-05COSD-1826-07COSD-1828-09COSD-1844-25COSD-1870-07S (1.85mm)OSD-1870-20S (1.85mm)OSD-19105-07SOSD-19115-15S | 2014 |
| Operative PliersEJY · Class 1 | Dental hand instruments | Lister | ACR-MP419144334668467049824984498649875019 3 more502261056251 | 2014 |
| Operative Cutting InstrumentEKD · Class 1 | Dental hand instruments | Maker | B0-3055B0-5050MS saw(Left)-AMS saw(Right)-AMS saw(Right)-SS MS saw(Left)-SSO-0860SO-0860-G1SO-0860-G2SO-0860-G3 24 moreSO-0860-G4SO-0860-G5SO-1338SO-1360SO-1538SO-1560SO-1838SO-1860SO-2060SP-3409SR-1438SR-2738SR-3238SR-4038SR-4038-ARSR-4038-ZSR-4060SR-4060-D2SR-4060-D3SR-4060-D4SR-4060-D5SR-4060-D6SR-4060-D7SR-4060-Z | 2019 |
| Surgical Rongeur ForcepsEMH · Class 1 | Dental hand instruments | Maker | ACR-HF021PHI MaxiPHI MicroPHI Mini4054534155426649 | 2014 |
| Bone PlateJEY · Class 2 | Maxillofacial plates & screws | Maker | ACR | 2012 |
| Preformed Tooth PositionerKMY · Class 1 | Retainers, expanders & headgear | Maker | Pre-Ortho Type1-LHPreOrtho InitialPreOrtho Type1-LSPreOrtho Type1-MHPreOrtho Type1-MSPreOrtho Type1-SHPreOrtho Type1-SSPreOrtho Type2-MHPreOrtho Type2-MSPreOrtho Type3-LH 5 morePreOrtho Type3-LSPreOrtho Type3-MHPreOrtho Type3-MSPreOrtho Type3-SHPreOrtho Type3-SS | 2019 |
| Endosseous Dental Implant AccessoriesNDP · Class 1 | Implant instruments & surgical kits | Maker | LEB-15CLEB-20CLEB-23CLEB-SMSLEB-U(BS)LEB-U2(BS)LEB12LEB15LEBCLEBC-HP 42 moreLEBOLEBO-MPRDB-KBERDB-MSESDB-1265X1SDB-15CSDB-15C-60SDB-15C-75SDB-15C-82SDB-1675X1SDB-20C-70SDB-20C-80SDB-20C-90SDB-20C-C-SQSDB-23C-60SDB-23C-90SDB-SLSDB-SMSSDB-U(BS)SDB-U2(BS)SDB12SDB15SDBCSDBC-HPSDBOSDBO-MPSDBU-CSEB-15CSEB-20CSEB-20SQSEB-23CSEB-SLSEB-SMSSEB-U(BS)SEB-U2(BS)SEB12SEB15SEBCSEBC-HPSEBOUEB-20CUEB-20C(11) | 2014 |
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 Biomaterials Korea, Inc. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 21 Aug 2023 | K222245 | ACR Screw System | OAT Orthodontic Endosseous Implant |
| 30 Aug 2018 | K173623 | Anchor plate | OAT Orthodontic Endosseous Implant |
| 8 Dec 2011 | K110926 | BONE PLATE; BONE SCREW | JEY Bone Plate |
| 26 Sep 2011 | K111809 | SL TYPE ORTHODONTIC ANCHOR SCREWS, SPL TYPE ORTHODONTIC ANCHOR SCREWS | OAT Orthodontic Endosseous Implant |
| 26 Jul 2007 | K063495 | C TYPE, CT TYPE, AND SPECIAL TYPE ORTHODONTIC ANCHOR SCREWS | OAT Orthodontic Endosseous Implant |
Some of these clearances are listed with FDA today by another company: Specialty Appliances, LLC (1).
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BIOMATERIALS KOREA INC.FDA reg. 3005515228 | Hanam-si Gyeonggi, South Korea | Foreign exporter, Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 9080640). 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.