Dental device manufacturers in South Korea
204 companies have an FDA-registered establishment in South Korea, across 218 sites. 193 manufacture dental devices there or own their specifications.
What they make
Implant instruments & surgical kits63Dental hand instruments46Implant abutments41Dental implants38Surgical drills & motors29Impression trays19Intraoral scanners19Dental X-ray units19Toothbrushes18Dental ceramics & zirconia14Floss & interdental cleaners14Retainers, expanders & headgear14Dental burs & diamonds13Dental needles & syringes13
| Company | Country | Role | Brands and models listed | Clearances | Latest |
|---|---|---|---|---|---|
| Dentis Co., Ltd. | South Korea | Maker | Dentis Dental Implant System · Dentis i-Clean System · Dentis I-FIX Abutment · Dentis s-Clean Abutment Mini · +517 | 37 | 2026 |
| ARUM DENTISTRY Co., Ltd | South Korea | Maker | Abutment Screw · Angled Abutment · Angled Abutment Mini · Cemented Abutment · +135 | 17 | 2025 |
| Mediclus Co., Ltd | South Korea | Maker | Any-Com · Any-Com Bulk · Any-Com Flow · Any-Com Kit · +33 | 15 | 2026 |
| Megagen Implant Co., Ltd. | South Korea | Maker | Abutment Screw · Advanced Intermezzo System · AnyOne External Implant System · AnyOne Internal Implant System · +233 | 30 | 2026 |
| Spident Co., Ltd. | South Korea | Maker | Core It Dual · EsCom 100 · EsCom250 · EsFlow · +35 | 22 | 2026 |
| Osstem Implant Co., Ltd. | South Korea | Maker | EK Dental Implants and Abutments · EK Multi Angled 30 Degree Abutment · ET Abutment System · ET Angled Abutments · +367 | 68 | 2026 |
| DiaDent Group International | South Korea | Maker | DIAFIL · DIAFIL Bulk FLOW · DIAFIL Capsule · DIAFIL Capsule Type · +51 | 24 | 2026 |
| Ray Co., Ltd, | South Korea | Maker | R2 Studio Q · RAYPreMiere · RAYQuantum · RAYSCAN ?-Expert3D · +36 | 21 | 2026 |
| Izenimplant Co., Ltd. | South Korea | Maker | ZENEX Implant System · ZENEX Implant System_Long · ZENEX Implant System_Narrow · ZENEX Implant System_R-System · +201 | 8 | 2026 |
| Cowellmedi Co., Ltd. | South Korea | Maker | INNO SLA Mini Plus® Implant System · INNO SLA Sub Narrow Implant System · INNO SLA Sub Ti-base System · INNO SLA Submerged Implant System · +4 | 14 | 2025 |
| Ossvis Co., Ltd. | South Korea | Maker | LL Implant System · LL Mini Onebody Implant · LL Temporary Cap · LW Abutment Screw · +143 | 7 | 2024 |
| VATECH Co., Ltd. | South Korea | Maker | Green X 12 Plus / Green X Plus (Model: PHT-70CHS) · Green X 12 SE (Model : PHT-40CHS) · Green X 21 (Model : PHT-90CHO) · VistaPano S 2 (Model: VistaPano S) · +1 | 33 | 2026 |
| GENOSS Co., Ltd. | South Korea | Maker | AMT0010A05 · AMT0010A1 · AMT0010A2 · AMT0010A3 · +3,789 | 23 | 2025 |
| Genoray Co., Ltd. | South Korea | Maker | GenX-CR · GT300 · GT300-C · PAPAYA · +20 | 14 | 2025 |
| Graphy, Inc. | South Korea | Maker | TERA HARZ · Tera Harz II · TERA HARZ DENTURE · Tera Harz Hard Denture · +3 | 6 | 2025 |
| Meta Biomed Co, Ltd | United States | Maker | ADSEAL · ADSEAL Plus · CeraPutty · CeraSeal · +31 | 24 | 2024 |
| MICRO-NX Co., Ltd. | South Korea | Maker | Choice Pro · ELEC ENGINE, Dental Engine for Implant Surgery (Model: ISE-170) · ELEC ENGINE, Dental Engine for Implant Surgery (Model: ISE-170C) · ELEC ENGINE, Dental Engine for Implant Surgery (Model: ISE-170L) · +21 | 7 | 2025 |
| Saeshin Precision Co., Ltd. | South Korea | Maker | ACL(B)-61I, ACL(B)-62I, ACL(B)-63I, ACL(B)-65I, ACL(B)-04C · AHP-85-SS · DENTIS DIP20 · MEARA; MEAHP · +21 | 16 | 2026 |
| Shinhung Mst Co., Ltd. | South Korea | Maker | MagDen Implant System · SI · SM · ST · +714 | 7 | 2023 |
| Digimed Co., Ltd. | South Korea | Maker | Dhx-70h · DIOX-602 · Hybrid C70 · HYBRID Pro · +7 | 6 | 2023 |
| PURGO BIOLOGICS Inc. | South Korea | Maker | THE Graft · THE Graft Collagen · CYTOSHIELD · OpenTex · +2 | 5 | 2024 |
| Simda Co., Ltd. | South Korea | Maker | Lab Analog · Scan Body · SIMDA Abutment | 3 | 2025 |
| Vericom Co., Ltd. | South Korea | Maker | DENFIL · DENFIL FLOW · SPACER · Vonflex Heavy, Vonflex Light · +8 | 20 | 2026 |
| Neobiotech Co., Ltd. | South Korea | Maker | CMI implant EB System · CMI Implant IS II active · CMI IMPLANT IS SYSTEM · CMI implant IT System · +318 | 17 | 2024 |
| InnoBioSurg Co.,Ltd | South Korea | Maker | AMII Implant Closing Screw · AMII Implant Healing Cap · AMII Implant Healing Cap Screw · AMII Implant System · +174 | 15 | 2022 |
| Biotem Co., Ltd. | South Korea | Maker | AR_N SLA Type Implant System · AR_N Type Implant System · Bone Level Fixture · BR SLA Type Implant System · +38 | 6 | 2023 |
| Hass Corp. | South Korea | Maker | Amber LiSi-POM Series · Amber LiSi-POZ Series · Amber Mill Meso · Amber Mill Q Series & Amber Mill Direct Series · +6 | 6 | 2026 |
| WARANTEC Co., Ltd. | South Korea | Maker | FIU36085 · FIU36100 · FIU36115 · FIU36130 · +1,396 | 4 | 2023 |
| DENTALMAX Co., Ltd | South Korea | Maker | LUXEN 5G · LUXEN CL Dental Liquid · LUXEN Smile · LUXEN Zr | 3 | 2024 |
| SNUCONE Co., LTD. | South Korea | Maker | SNUCONE BONE LEVEL IMPLANT SYSTEM · SNUCONE TISSUE LEVEL IMPLANT SYSTEM · BONE FLATTENER · BONE TRIMMER · +73 | 2 | 2023 |
| ZEROS Co., Ltd. | South Korea | Maker | IOS Abutment · STERI-OSS Implant System · ZEROS Dental Implant System · Abutment Lab Analog · +36 | 2 | 2026 |
| Oneday Biotech Co., Ltd. | South Korea | Maker | I DO IMPLAMT · Oneday Biotech Implant · Oneday Mini Implant System · Oneday Implant Abutment · +33 | 2 | 2024 |
| HDI Inc. | South Korea | Maker | DENU Composite Resin · DENU Flow Resin · Denu Block-Out Resin · Denu Jig Handy · +19 | 2 | 2022 |
| PICOPACK Inc. | South Korea | Maker | WeRay · MDP · WeSensor | 2 | 2024 |
| MEDPARK.Co., Ltd. | South Korea | Maker | Endobon® Bovine Xenograft Moldable · Endobon® Bovine Xenograft Particulate | 2 | 2026 |
| MGNEWTON Ltd. | South Korea | Maker | CURA-Temp · ELEC Master, ELEC Master Dual | 2 | 2023 |
| Unidental Co., Ltd. | South Korea | Maker | UNIdental Symphony Implant System | 2 | 2026 |
| LAON MEDI Inc. | South Korea | Maker | Laon Ortho | 2 | 2025 |
| Tns Co., Ltd. | South Korea | Maker | Serafin® | 2 | 2025 |
| Dentium USA | United States | Maker | AAB154515H · AAB154515HE · AAB154515HL · AAB154515HT · +1,570 | 23 | 2022 |
| DIO Corporation | South Korea | Maker | DIO Ball Cap · DIO Dental Implant System · Dio Protem Implant System · DIO Retainer · +508 | 14 | 2023 |
| KJ Meditech Co., Ltd. | South Korea | Maker | Anchor plus · Conical Plus Implant System · HERO I DENTAL IMPLANT SYSTEM · HERO II DENTAL IMPLANT SYSTEM · +27 | 13 | 2022 |
| Jeil Medical Corporation | South Korea | Maker | Bone Fixation Screw Kit · GBR System · JEIL BONE FIXATION SYSTEM · Leforte MMF System · +40 | 9 | 2026 |
| Maruchi | South Korea | Maker | AH Plus® Bioceramic Sealer · CleaniCal · ENDOCEM MTA · ENDOCEM MTA PREMIXED REGULAR · +21 | 8 | 2023 |
| Hdx Will Corp. | South Korea | Maker | Dental X-ray system · DENTRI Max (DENTRI?, DENTRI-C?, DENTRI-S?) · DENTRI? series (DENTRI?, DENTRI-C?, DENTRI-S?) · DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) · +6 | 6 | 2021 |
| Biomaterials Korea, Inc. | South Korea | Maker | ACR · Anchor Plate · OAS-T1809-SP · OAS-T1811-SP · +311 | 5 | 2023 |
| Good Doctors Co., Ltd. | South Korea | Maker | CL-DC20 · CL-DC21 · CL-DP40 (Dr's Light CHOICE) · CL-DP40 (Dr's Light PRIME) · +11 | 5 | 2023 |
| Rayence Co., Ltd. | South Korea | Maker | — | 5 | 2022 |
| Dentium Co.,Ltd(ICT branch) | South Korea | Maker | bright CT · bright MCT · rainbow CT · rainbow MCT · +3 | 3 | 2023 |
| Sewon Medix, Inc. | South Korea | Maker | BIOTHREAD BT3 Implant System · IH Implant System · BONE TRIMMER (SBT50) · Drill & Drill Accessories (Guide Drill, Drill Extension, Twist Drill, Pilot Drill, Cortical Drill, Drill Stopper) · +95 | 2 | 2023 |
| DMAX Co., Ltd. | South Korea | Maker | ADD-Z · Alpha+ · CAMeleon Coloring Liquid · Chang's Liquid · +15 | 2 | 2025 |
| Shinhung Company, Ltd. | South Korea | Maker | G7, Dental Operative Unit and Accessories · TAURUS C1 · K-irrigator tips · SHINJECT · +10 | 2 | 2023 |
| AIOBIO Co., Ltd. | South Korea | Maker | LINKDENS VU · Qrayview pro · MouthCAM Pro · Qraypen, Qraypen C · +3 | 2 | 2024 |
| Remedi Inc. | South Korea | Maker | MobileX T-100 · REMEX-GR100 · REMEX-T100 · T-100 · +1 | 2 | 2024 |
| Eclectic Co., Ltd. | South Korea | Maker | PreXolid Abutment Screw 2.10mm Hex1.20mm ASMR · PreXolid Abutment Screw 2.10mm Hex1.23mm ASPM · PreXolid Abutment Screw 2.10mm Hex1.74mm ASSR · PreXolid Abutment Screw 2.20mm Hex1.74mm ASSM · +579 | 1 | 2024 |
| Cybermed Inc. | South Korea | Maker | ABT. Profiler · Anchor Drill · Bone Flatter · Bone Profiler · +133 | 1 | 2022 |
| DIMPLO Ltd. | South Korea | Maker | Anchor Drill · Bone Flat Drill · Core Drill · Cortical Drill · +69 | 1 | 2025 |
| ALLONUS Tech Co., Ltd. | South Korea | Maker | ASC Screw Driver · Digital Analog · GM Screw Driver · Lab Analog · +10 | 1 | 2024 |
| GeoMedi Co., Ltd. | South Korea | Maker | Geo Abutment · Geo CMFit Abutment · Geo Multibase Abutment · Geo Screw · +9 | 1 | 2025 |
| HYUNDAI BIOLAND Co., Ltd. | South Korea | Maker | Oradapt · OsseoSeal · OssGuide · OsteoFlex · +3 | 1 | 2026 |
| Vatech mcis Co., Ltd. | South Korea | Maker | Chairside Zirconia · Perfit CL · Perfit FS · Perfit FS Dental Zirconia Fully Sintered Block · +3 | 1 | 2023 |
| MK Meditech | South Korea | Maker | ATOZ Expander, ATOZ Key, Model ATOZ, Guide ATOZ · ATOZ Utility Wire · ATOZ Screwdriver · ATOZ Mini-Screw · +1 | 1 | 2021 |
| Id Korea Co., Ltd. | South Korea | Maker | ID Light Cure System | 1 | 2025 |
| ODS Co., Ltd. | South Korea | Maker | ODS Clear Resin - Retainer · ODS Surgical Guide · Scan Cure (SC-80) · Clear Miracle | 1 | 2025 |
| B&E KOREA Co., Ltd. | South Korea | Maker | Chemi-SiL Bite-Blu · Chemi-SiL HB · Chemi-SiL LB | 1 | 2024 |
| DenQ Co., Ltd. | South Korea | Maker | DenQ Sub SLA Implant System · DenQ Accessories | 1 | 2024 |
| IDIS Co. Ltd. | South Korea | Maker | Ni2 Implant System · S-Plant Dental Implant System | 1 | 2023 |
| VSI Co., Ltd. | South Korea | Maker | CLAROX · CLAROX X4 · X4 | 1 | 2022 |
| highness Co.,Ltd. | South Korea | Maker | HIGHNESS IMPLANT SYSTEM | 1 | 2024 |
| Doctus Global | South Korea | Maker | Easy On Universal Glaze & Stain | 1 | 2023 |
| DRTECH Corporation | South Korea | Maker | XERO ? | 1 | 2024 |
| ECOTRON Co., Ltd. | South Korea | Maker | Extraoral source x-ray system DT-703, ProX Go | 1 | 2022 |
| Hudens Bio Co., Ltd. | South Korea | Maker | BONTREE PLUS | 1 | 2026 |
| PDX Co., Ltd. | South Korea | Maker | nova | 1 | 2026 |
| Rgorithm Korea | South Korea | Maker | TRUST | 1 | 2023 |
| Smartooth Co., Ltd. | South Korea | Maker | SmarTooth | 1 | 2024 |
| Solbaro Co.,Ltd. | South Korea | Maker | SNOR LOCK | 1 | 2022 |
| Dxm Co., Ltd. | South Korea | Maker | Coltolux LED 2 · Cybird Gold · Cybird LED Curing Light · Cybird Ultra · +29 | 6 | 2020 |
| DMETEC Co., LTD | South Korea | Maker | ULTRASONIC SURGERY · ULTRASONIC SURGERY MACHINE · CLEANSE S+ ULTRASONIC SCALER · Compact S, Compact S(LED) · +2 | 5 | 2017 |
| Medimecca Co., Ltd. | South Korea | Maker | Biothread Dental Implant System · Biothread Dental Implant Systems · CHAORUM Implant System · DISOAR Implant System · +126 | 4 | 2020 |
| CSM Implant | South Korea | Maker | CSM Submerged3-L Implant System · implant1 · implant2 · implant3 · +43 | 4 | 2018 |
| NIBEC Co Ltd | South Korea | Maker | bone grafting material, animal source · Creos Xenogain · Creos Xenogain Collagen · Instradent Xenograft · +10 | 4 | 2015 |
| Dexcowin Co., Ltd. | South Korea | Maker | ADX 4000 · Cocoon DX-7017 · Cocoon DX-7020 · COCOON SOLO (DX-7020s) · +8 | 4 | 2017 |
| OSTEONIC Co., Ltd. | South Korea | Maker | OPTIMUS CMF System · POWER SYSTEM · T4A.10010 · T4A.10010F · +39 | 3 | 2021 |
| GNI Co., LTD | South Korea | Maker | ROSA Bracket · VENUS Bracket, ROSE Bracket · GNI Ortho · WIRE · +7 | 3 | 2021 |
| DENTALL Co., Ltd. | South Korea | Maker | B&Lite S | 3 | 2017 |
| Dentos, Inc. | South Korea | Maker | LAB-100-12 · LAB-100-500 · LAB-120-12 · LAB-120-500 · +904 | 2 | 2019 |
| Surgident Co., Ltd. | South Korea | Maker | GBR System SD-Screw, Bone Tac · GBR System Titanium Mesh · DR.PARK Needle Holder · DR.PARK Tissue Forceps · +76 | 2 | 2019 |
| Dentkist, Inc. | South Korea | Maker | CharmFil Flow · CharmFil Plus · CharmFil Plus Caps · Flow Resin ALOOZ · +13 | 2 | 2020 |
| World Bio Tech Co Ltd | South Korea | Maker | BIJOU Orthodontic Ceramic Bracket · SELPRO BRACKET BRIGHT BRACKET · SMART Wires ; NiTi Archwire, Stainless Steel Archwire, Copper NiTi Archwire, Reverse Curve NiTi Archwire · Elastomerics ; Intraoral Elastics, Power Chain, Ligature Ties, Separators, Thread, Tubing, Rotation Wedge · +5 | 2 | 2016 |
| HRS Co., Ltd. | South Korea | Maker | Sildent Bite · Sildent Fast Heavy Body · Sildent Fast Light Body · SILDENT HEAVY BODY · +3 | 2 | 2018 |
| B&L Biotech Co., Ltd. | South Korea | Maker | AC adaptor protector cap · Alpha · Alpha Enclosure · Alpha II · +431 | 1 | 2006 |
| HT Co., Ltd. | South Korea | Maker | MISO NiTi Dimpled Archwire MDL-14 · MISO NiTi Dimpled Archwire MDL-16 · MISO NiTi Dimpled Archwire MDL-1616 · MISO NiTi Dimpled Archwire MDL-1622 · +143 | 1 | 2011 |
| Sherpa | South Korea | Maker | Deli-Temp · E&E Extended Working Time Denture Soft Reline Combo Kit · E&E Extended Working Time Denture Soft Reline Kit · E&E Fast Set Pro Denture Soft Reline Kit for Upper & Lower Dentures · +27 | 1 | 2011 |
| T Strong, Inc. | South Korea | Maker | U fit Dental Implant System · Anchor Drill · Anchor Driver · Drill Extension · +16 | 1 | 2014 |
| Handae Chemical Co., Ltd | South Korea | Maker | Delikit Bite Registration Premium · Delikit Heavy Body Premium · Delikit Light Body Premium · PERFECT BITE · +6 | 1 | 2004 |
| Seilglobal CO., Ltd | South Korea | Maker | Mirror system · Disposable Impression Tray · JB Tray, JBUT, JBLT, JBUTLT, JBUTR, JBLTR · Autoclavable Irrigation Tube · +11 | 1 | 2015 |
| U&C International Co., Ltd. | South Korea | Maker | BlueTooth · Chang's DA-vich · Chang's Iris · Everest · +5 | 1 | 2019 |
| BioMTA | South Korea | Maker | OrthoMTA(Mineral Trioxide Aggregate) · RetroMTA-OrthoMTA II · Smart MTA · OrthoMTA Needle Tips · +3 | 1 | 2014 |
| WinUs Technology Co., Ltd. | South Korea | Maker | Dexcam3 · Dexcam4 · Dexcam4 HD · GXC300 · +3 | 1 | 2004 |
| DMS Co., Ltd. | South Korea | Maker | AnyCheck IMT-100 · Dr. Plant · VAROGuide PreGuide | 1 | 2019 |
| Kwang Myung Daicom, Inc. | South Korea | Maker | Headgear · Mirror · Instrument | 1 | 2011 |
| F&B Technology Co., Ltd. | South Korea | Maker | Fit & Brilliant Dental Implant System | 1 | 2020 |
| Hans Biomed Corp. | South Korea | Maker | ExFuse(tm) II Putty · SurFuse(tm) II Putty | 1 | 2014 |
| Chiyewon Co., Ltd. | South Korea | Maker | — | 1 | 2015 |
| 8dent Inc. | South Korea | Maker | ADD-ON Implant System - ADAAM4010 · ADD-ON Implant System - ADAAM4020 · ADD-ON Implant System - ADAAM4030 · ADD-ON Implant System - ADAAM4040 · +1,652 | — | — |
| Osung Mnd Co Ltd | South Korea | Maker | Bone tack (BTKIT) · BEPDP13 · BSWDR1 · BSWDR1.3 · +1,608 | — | — |
| Covision Co., Ltd. | South Korea | Maker | AN-0011 · AN-0012 · AN-0013 · AN-0014 · +488 | — | — |
| TruAbutment Korea Co Ltd | South Korea | Maker | AOT & T-L Abutment · TruAbutment DS · TruAbutment DS, TruBase · TruBase · +170 | — | — |
| Dental Studio | South Korea | Maker | NSI Buddy · Mirror & Holder · Easy Surgical 360 Suction · TITANIUM SUCTION SET A TYPE · +115 | — | — |
| PointImplant Co Ltd | South Korea | Maker | Bone Profile Drill · Cortical Drill · Final Drill · Fixture Tap Drill · +65 | — | — |
| ACH Medical Co., Ltd. | South Korea | Maker | AIMGEN · Biogenesis Implant System - Aticon · Biogenesis Implant System - Kisses · IB · +48 | — | — |
| HANSUNG Company | South Korea | Maker | A BETTER TOOTHBRUSH · ADERERROR TOOTHBRUSH · ARTPEEL Toothbrush · BICHAEME Toothbrush · +51 | — | — |
| Kaiser Precision Co. | South Korea | Maker | Drill Extension · Lifting Drill · Lindemann Drill · Point Drill · +42 | — | — |
| OSSTEM ORTHODONTICS Inc. | South Korea | Maker | Clear Elect · Genesis- C · MAJESTY-SLC · Neocrystal Plus · +41 | — | — |
| HUMEDITECH Co., Ltd | South Korea | Maker | C-Bone Packer · Drill Extension · Fixture Driver Long and Short · G-Packer · +30 | — | — |
| De'O Tech Korea Co., Ltd. | South Korea | Maker | Atomy Kids Toothbrush · ATOMY ORAL CARE SYSTEM · ATOMY TOOTHBRUSH · Bass Toothbrush · +24 | — | — |
| Medit Corp. | South Korea | Maker | i500 · i600 · i700 · i700 wireless · +23 | — | — |
| one day dental partner | South Korea | Maker | kage RETAINER, SCREW EXPANSION, ORTHODONTIC · kage INSTRUMENT, DIAMOND, DENTAL · kage Light · kage Coating, denture hydrophilic, resin · +22 | — | — |
| DUNAMIS DENTAL Co., Ltd. | South Korea | Maker | Karam-AM · Karam-ANG · Karam-Delix · Karam-Lab · +16 | — | — |
| MCTBIO Co., Ltd | South Korea | Maker | BONE TAC · ORTHODONTIC SCREW · DENTAL IMPLANT DRILL · STAR JECT · +15 | — | — |
| Best Whasung, Co., Ltd | South Korea | Maker | abcOralcare · AVON Himalaya PinkSalt Toothbrush Medium · AVON Himalaya PinkSalt Toothbrush Soft · Bamboo Salt Charcoal Toothbrush Wide Head Ultra-Fine Bristles 3 Pack · +14 | — | — |
| C&C Co., Ltd. | South Korea | Maker | ELOWN Classico Toothbrush Medium · ELOWN Classico Toothbrush Soft · LiveOrals Children's Toothbrush · LiveOrals Ultra-Soft Bristle Toothbrush · +12 | — | — |
| Hans Korea | South Korea | Maker | Hans Korea · ICT · ICT 2D LONG · ICT MICRO · +9 | — | — |
| Atria Co. | South Korea | Maker | Atria | — | — |
| PNUAdd Co., Ltd. | South Korea | Maker | JB Fork Radi+, RAYeTray · JB Tray, JB Tray Radi+ · ADD POP BOW · PNUADD Standard Surgical KIT_Depth Gaouge, Torque Wrench · +9 | — | — |
| Welltooth Co., Ltd. | South Korea | Maker | CORE · DR.CARE · Miev Toothbrush · SCHUNGIT + GOLD / SCHUNGIT · +9 | — | — |
| DIGIRAY Corp. | South Korea | Maker | ClearVision CR · CR500 · Dental CR · EAI DxScan · +7 | — | — |
| Garnet Dentech | South Korea | Maker | Face Mask · Orthodontic Wire · Mouth Mirror · Crimpable hooks · +7 | — | — |
| Proxihealthcare | South Korea | Maker | TROMATZ-B-N, TROMATZ-B-S, P-WAVE-TB-S, PWAVE-TB-M · TROMATZ-DC Series · TROMATZ-GG1 · TROMATZ-GGC1 Series (Various Models) · +6 | — | — |
| Chung Song Industrial Co. | South Korea | Maker | SUNBURST · ABRASIVE STONE POINT · IMPRESSION TRAY · MOUNTED STONES · +1 | — | — |
| Hallim Point Implant Co., Ltd. | South Korea | Maker | CHALLENGE-EVER / HL-2060, HL2060A · ARTE · DENTAL UNIT & CHAIR (CHALLENGE · ECLIPSE · +4 | — | — |
| SMD Dental Laboratory | South Korea | Maker | Custom Abutment · Custom Abutments · orthodontic retainer · MAZIC Duro · +4 | — | — |
| Sure Dent Corporation | South Korea | Maker | Sure-Paste · Sure-Seal Root · RETRACTION CORD · Sure-Cord · +4 | — | — |
| DDS Inc. | South Korea | Maker | COMFORT+ · DM5000 · NEXOD · RAY Mill C · +3 | — | — |
| Huvitz Company Ltd | South Korea | Maker | IntraOral Scanner LS-100 · IntraOral Scanner LSO-100 · Lilivis CAD L-CAD · LS-100-TIP-3R · +3 | — | — |
| IDS Korea | South Korea | Maker | Porcelain Powder · Dentsply · E-MAX Crown · Porcelain Fused to Metal Crown · +2 | — | — |
| JISCOP Co., Ltd. | South Korea | Maker | Orthodontic Wire · Orthodontic Tube · Orthodontic Elastic Band · Orthodontic Wire Clamp · +3 | — | — |
| Medihub Co., Ltd. | South Korea | Maker | i-JECT BTS Warmer · i-JECT ON · I-JECT B · i-JECT BTS injector · +3 | — | — |
| Osstem Pharma Co., Ltd. | South Korea | Maker | WO-200 Osstem Wopick Cordless Oral Irrigator · WO-300 Osstem Wopick Combo Irrigator & Sonic Toothbrush · Osstem Double-wide Toothbrush · Vussen Double-wide Toothbrush · +3 | — | — |
| Samjung Corporation | South Korea | Maker | RED Toothbrush · Smiley(MyBeany) Toothbrush · Toof Toothbrush · Wangta Toothbrush · +3 | — | — |
| Lucky Industries Co., Ltd. | South Korea | Maker | Bamboosalt Toothbrush With Soft Bristle For Gum Health 4PK · Bamboosalt Toothbrush With Soft Bristle For Sensitive Teeth 4PK · Perioe Kids Toothbrush Dinosaur (Ages 3-5) · Perioe Kids Toothbrush Kakao (Ages 8-13) 1PK · +1 | — | — |
| Renewmedical Co., Ltd. | South Korea | Maker | Renew Tray G-1, Renew Tray G-2, Renew Tray G-3, Renew Tray G-4, Renew Tray G-5 · Renew Tray MG-2, Renew Tray MG-4, Renew Tray MG-7, Renew Tray MP-2 · Renew Tray MP-4, Renew Tray MP-7, Renew Tray RG-1, Renew Tray RG-3 · Renew Tray P-1, Renew Tray P-2, Renew Tray P-3, Renew Tray P-4, Renew Tray P-5 · +1 | — | — |
| SAEYANG Co.,Ltd 韩国（株）世洋 | South Korea | Maker | Endo E Class · Ki-20 · CanalPro CL2 · Endo A Class · +1 | — | — |
| Daekwang Idm | South Korea | Maker | Abutment, implant, dental, endosseous · IMPLANT, ENDOSSEOUS, ROOT-FORMAbutment, implant, dental, endosseous · HANDLE, INSTRUMENT, DENTAL | — | — |
| Dental Care Co., Ltd. | South Korea | Maker | Dental Care Tooth Brush · Manual interdental brushes · Silicon Tooth Brush · Dental Care Tongue Scraper | — | — |
| DOF Inc | South Korea | Maker | PIM KIT · PIM Scanbody · FREEDOM Air · FREEDOM i | — | — |
| DOIFF Co., Ltd. | South Korea | Maker | DSSK01, LCD1525, LCD1828, LCD2228, LCD2535, LCD2838, LCD3238, LCD3545, LCD3848, LCD4248, LCD4555, LCD4858, LCD5258 · Sinus Simple Kit · Aurora / X9, X5, X5 Plus · ML100 / ML100A, ML100B | — | — |
| Evidence Implant Inc. | South Korea | Maker | Internal Hex Implant System · SD2207 SD2212 SD2214 SD2215 SD2807 SD2812 SD2814 SD2815 SD3507 SD3512 SD3514 SD3515 SD4215 · OPUMC35 OPUMC40 OPUMB35 OPUMB40 OPURC OPURB OFMM OFMR41 OFMR41b OFMW55 OFMW55b OFMMS OFMRS | — | — |
| HUB Biotech Co., Ltd. | South Korea | Maker | AOX Edentulous Scan · Derbarzt Edentulous Scan · Scan Body · TIE SCANBODY | — | — |
| Innovaid Co. | South Korea | Maker | Teeth, Artificial, With Metal Insert · Dentlink Zirconia Crown · Dentlink Implant Surgical Guide, Resin · Dentlink Titanium Scan Body | — | — |
| Manix Co., Ltd. | South Korea | Maker | Cylinder · Endmill · Tool · Manix MA-4, MD-4, MD-5, ZX-4, ZX-4SA, ZX-4SD, ZX-5SA, XZ-5SD, PT-1, ZX-4A, CS-41 | — | — |
| Sang Si | South Korea | Maker | Denti-clinic interdental brush · Easy Scaling toothbrush · Embossing toothbrush · Life Modern toothbrush | — | — |
| Wedent Co., Ltd. | South Korea | Maker | Wedent interdental brush · Wedent toothbrush · Wedent dental floss · Wedent Tongue Cleaner | — | — |
| Aceonedent Korea lnd. Co. | South Korea | Maker | GP Trimmer · ACEONE-ENDO | — | — |
| Arcreal Inc. | South Korea | Maker | ARC-IOS100, ARC-IOS100H · Arcscan · Intraoral Scanner | — | — |
| Dentozone Corporation | South Korea | Maker | eBite3S Blue Light · Accessories for Suction Connector · 99 Suction Block | — | — |
| DSM Holdings Co., Ltd | South Korea | Maker | DeepCAM · EZ-CAM160K · EZ-CAM520K | — | — |
| Illuco Co, LTD | South Korea | Maker | IDM-1C14-B · IDM-1C14-DB · IHL-2000 | — | — |
| SMD Solution Co., Ltd. | South Korea | Maker | COMORAL Oral Irrigation Unit · Comoral H · Comoral Oral Irrigation Unit | — | — |
| Adwin Korea Corporation | South Korea | Maker | Baby Teeth Wipes · Finger Teeth Wipes | — | — |
| Crown Makers | South Korea | Maker | CM-202402 · CM-202401 | — | — |
| HLB Co., LTD. Healthcare | South Korea | Maker | Gum & Tooth care wipes · Oral care tissue | — | — |
| Inno Dental Co Ltd | South Korea | Maker | Q.P Fiber Post Plus Refill · Q.P. Fiber Post Plus | — | — |
| iRay Korea Limited | South Korea | Maker | Pluto0001X · Pluto0002X | — | — |
| KNK | South Korea | Maker | Glister Multi-Action Power Toothbrush · Glister Multi-Action Power Toothbrush Refill | — | — |
| Poskom Co Ltd | South Korea | Maker | REXTAR X · Xcam | — | — |
| RB Dental | South Korea | Maker | Dental Crown · Porcelain Fused to Metal Crown | — | — |
| Well Medical | South Korea | Maker | AUTOTORQ-35 · OsseoScrape | — | — |
| Xenosys Co Ltd | South Korea | Maker | XDL4 · L2SX5 | — | — |
| BTB Korea Co.,Ltd | South Korea | Maker | SNOR-STOP plus | — | — |
| CG Bio Co., Ltd. | South Korea | Maker | Bongros | — | — |
| DANY BMT Co., Ltd. | South Korea | Maker | Orthodontic wire | — | — |
| Deok YU Co. | South Korea | Maker | Doctor plotka`s toothbrush | — | — |
| Digital Dental Fusion | South Korea | Maker | Novaflow | — | — |
| Gaju Dental Inc. | South Korea | Maker | Preformed Crown | — | — |
| Imagoworks Inc. | South Korea | Maker | Dentbird Crown | — | — |
| INNO3D Co., Ltd. | South Korea | Maker | DENSFLO SCAN (MODEL:IDT-1000) | — | — |
| MDX Co., Ltd. | South Korea | Maker | Air Compressor (Models: AnyAir2, AnyVac40) | — | — |
| MINISH DENTAL LAB Co.,Ltd | South Korea | Maker | MINISH Veneer | — | — |
| Morpheus Co., Ltd. | South Korea | Maker | FACECAST DENTAL | — | — |
| Shinsaegi Medi-Tech Co., Ltd. | South Korea | Maker | Guide Drill (SST, SRT, IT) | — | — |
| SMENG co.,ltd. | South Korea | Maker | SM ENG CO.,LTD, | — | — |
| Smilecad | South Korea | Maker | NT-TAINER | — | — |
| Smileconcept Dental Lab | South Korea | Maker | ZIRCONIA CROWN | — | — |
| Sungshim Medicare Co.,Ltd. | South Korea | Maker | Sungshim Dental Needle | — | — |
| Uzinmedicare Co., Ltd. | South Korea | Maker | Spectra STERILIZATION | — | — |
| Yes Dental Lab | South Korea | Maker | Dental prosthesis | — | — |
| 韩国速压科技有限公司SOYAGREENTEC Co.,Ltd. | South Korea | Maker | OSTEON | — | — |
| Amskorea Co.,ltd | South Korea | Maker | — | — | — |
| BCC Korea Co. Ltd. | South Korea | Maker | — | — | — |
| CK Dental Ind Co Ltd | South Korea | Maker | — | — | — |
| EPDENT Co., Ltd. | South Korea | Maker | — | — | — |
| LG H&H Co., Ltd. | South Korea | Foreign exporter | PERIOE Thera-White Instant Whitening LED Light · AVON Himalaya PinkSalt Toothbrush Medium · AVON Himalaya PinkSalt Toothbrush Soft · AVON Whitening Essentials Toothbrush Medium Charcoal · +69 | — | — |
| HI Medical Co., Ltd. | South Korea | Foreign exporter | GC · 3M ESPE · Kulzer · Dentsply · +2 | — | — |
| Zapalign Inc. | South Korea | Foreign exporter | Material, tooth shade, resin · CEMENT, DENTAL · PROVI CEMENT · MATERIAL, IMPRESSION · +5 | — | — |
| Greenpia Technology Inc. | South Korea | Contract sterilizer | J2A Dental Implant System, J2C Dental Implant System · One Plus Implant System · Osseofuse Dental Implant System · Absorbent Paper Points · +1 | — | — |
| Atomy Co., Ltd. | South Korea | Foreign exporter | Atomy Kids Toothbrush; ATOMY ORAL CARE SYSTEM; ATOMY TOOTHBRUSH | — | — |
| Dasol International Ltd. | South Korea | Contract sterilizer | Sani-Needle | — | — |
| SG Healthcare Co. Ltd | South Korea | Repacker / relabeler | Hasla | — | — |
| Sprinkle Co., Ltd. | South Korea | Foreign exporter | Pure-Aid | — | — |
| Sumsei Co., Ltd. | South Korea | Foreign exporter | Wedent Tongue Cleaner | — | — |
| Duad Co., Ltd. | South Korea | Repacker / relabeler | — | — | — |
| Grand S Korea Co., Ltd. | South Korea | Foreign exporter | — | — | — |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026