Dental device and equipment manufacturers

3,592 companies list a dental device with FDA. 3,025 of them make devices or own their specifications; the rest repack, relabel, import or distribute. They run 4,089 registered establishments in 73 countries.

Most active manufacturers

Ranked by 510(k) clearances in the last five years, then by all clearances and by the number of brand and model names listed.

Browse by device
CompanyCountryRoleBrands and models listedClearancesLatest
Institut Straumann AGSwitzerlandMakerAbutment components · CARES Abutment · CARES TAN Abutment · CARES® Advanced Bar · +3122122026
Dentsply Sirona, Inc.United StatesMakerAnkylos Cercon Balance · Ankylos Temporary Abutment Balance · Anti rotation cementing cap for connect abutment · Atlantis Abutment in Zirconia for 3i Certain MicroMini Implants · +2531482026
Prismatik Dentalcraft, Inc.United StatesMakerBruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, A1 · BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, A2 · BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, A3 · BruxZir® NOW SRC for Glidewell HT™ Implant System 3.5/4.3mmD, A3.5 · +4,805562026
Terrats Medical, S.L.SpainMakerArgen · DESS Dental Smart Solutions · DIRECTarch · INTEGRATED DENTAL SYSTEMS · +2232026
Dentis Co., Ltd.South KoreaMakerDentis Dental Implant System · Dentis i-Clean System · Dentis I-FIX Abutment · Dentis s-Clean Abutment Mini · +517372026
ARUM DENTISTRY Co., LtdSouth KoreaMakerAbutment Screw · Angled Abutment · Angled Abutment Mini · Cemented Abutment · +135172025
Mediclus Co., LtdSouth KoreaMakerAny-Com · Any-Com Bulk · Any-Com Flow · Any-Com Kit · +33152026
Megagen Implant Co., Ltd.South KoreaMakerAbutment Screw · Advanced Intermezzo System · AnyOne External Implant System · AnyOne Internal Implant System · +233302026
Spident Co., Ltd.South KoreaMakerCore It Dual · EsCom 100 · EsCom250 · EsFlow · +35222026
Aidite (Qinhuangdao) Technology Co., LtdChinaMakerAidite · Biomic Color Opaque · Dental Crystallized Ceramics (HT,LT,ST) · Dental Zirconia Ceramic · +30162026
Voco GmbHGermanyMakerAdmira · Admira Bond · Admira Caps · Admira Flow · +1521172026
Nakanishi, Inc.JapanMakerA450L · AB450L SU · AIR MOTOR HANDPIECE TN-102 · AK400L · +792372026
Align Technology, Inc.United StatesMakeriGo · iGo Plus · Invisalign ART · Invisalign Assist · +83162026
Rizhao HuGe Biomaterials Company, Ltd.ChinaMakerDual Cure Resin Cement · TopCEM Dual Cure Resin Cement · TopCEM-Try in Veneer Try-in Gel · TopCEM-Veneer Light Cure Veneer Cement · +10132025
Nobel Biocare Services AGSwitzerlandMakerAbutment Blank · Abutment Screw NobelReplace · Angulated Screw Channel (ASC) Abutment · Attachment System · +364942026
Osstem Implant Co., Ltd.South KoreaMakerEK Dental Implants and Abutments · EK Multi Angled 30 Degree Abutment · ET Abutment System · ET Angled Abutments · +367682026
DiaDent Group InternationalSouth KoreaMakerDIAFIL · DIAFIL Bulk FLOW · DIAFIL Capsule · DIAFIL Capsule Type · +51242026
Shofu IncJapanMakerBEAUTICEM VENEER KIT · BEAUTIFIL · BEAUTIFIL BULK · BEAUTIFIL BULK FLOWABLE · +162962025
Geistlich Pharma AGSwitzerlandMakerCombi-Kit Collagen · Geistlich Bio-Gide® · Geistlich Bio-Gide® Compressed · Geistlich Bio-Gide® Forte · +10302025
Ray Co., Ltd,South KoreaMakerR2 Studio Q · RAYPreMiere · RAYQuantum · RAYSCAN ?-Expert3D · +36212026
NeocisUnited StatesMakerYomi Robotic System · Yomi S Robotic System192026
Elos Medtech Pinol A/SDenmarkMakerAbutment Blank · Abutment Screw · Abutment Screw NP · Access Abutment · +79142026
Izenimplant Co., Ltd.South KoreaMakerZENEX Implant System · ZENEX Implant System_Long · ZENEX Implant System_Narrow · ZENEX Implant System_R-System · +20182026
SprintRay Inc.United StatesMakerApex Base (Light Pink, Original Pink, Dark Reddish Pink, Opaque Original Pink) · Apex Flex - Light Pink · Apex Flex - Standard Pink · Ceramic Crown (Bleach, A1, A2, A3, B1, B3, C2, D2, D3) · +2482026
GC America Inc.United StatesMakerBULK FujiCEM(AutoCompatible) · CAVITRON · Ceramic Primer · Ceramic Primer II · +3651372026
Hiossen Inc.United StatesMakerEK Dental Implants and Abutments · EK Digital Abutments · EK Multi Angled 30 Degree Abutment · ET Abutment System · +87262026
Zest Anchors, LLCUnited StatesMakerR-Tx Abutments262026
Cowellmedi Co., Ltd.South KoreaMakerINNO SLA Mini Plus® Implant System · INNO SLA Sub Narrow Implant System · INNO SLA Sub Ti-base System · INNO SLA Submerged Implant System · +4142025
Guilin Woodpecker Medical Instrument Co., Ltd.ChinaMakerAi-surgery, Surgic smart · Dental Scaler and Air Polisher · Love Hygiene Air · Piezo Bone Surgery · +85122025
Ossvis Co., Ltd.South KoreaMakerLL Implant System · LL Mini Onebody Implant · LL Temporary Cap · LW Abutment Screw · +14372024
Sybron Dental SpecialtiesUnited StatesMakerAlert · Alert Condensable Composite · Artiste Nano Composite · Build-It FR · +5532032026
Ultradent Products, Inc.United StatesMakerAmelogen Plus · Composite Wetting Resin · Forma S · J-Temp · +207952026
KLS Martin SE & Co. KGGermanyMaker—432026
Kulzer, LLCUnited StatesMakerCuttersil Hardener · Cuttersil Light · CUTTERSIL MUCOSA · Cuttersil Putty Plus · +110372026
VATECH Co., Ltd.South KoreaMakerGreen 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) · +1332026
GENOSS Co., Ltd.South KoreaMakerAMT0010A05 · AMT0010A1 · AMT0010A2 · AMT0010A3 · +3,789232025
Southern Implants, Inc.South AfricaMakerCo-Axis Implants · DC Implants and Accessories · Deep Conical Implants and Accessories · External hex anatomical abutments · +50222024
Talladium Espana, SLSpainMakerDynamic Abutment Solutions · Biotech Dental92026
Prevest Denpro LimitedIndiaMakerFusion Core DC Flo · Fusion Flo · Fusion Flo SE · Fusion I Seal · +4972024
Implant Protesis Dental 2004, S.L.SpainMakerAngled Multi-unit Screw M1.4 · Angled Multi-unit Screw M1.6 · Angled Multi-unit Screw M1.8 · Angled Multi-unit Screw M2 · +1,50362026
Foshan COXO Medical Instrument Co., Ltd.ChinaMakerLED Curing Light; DB686 NANO, DB686 SWIFT · LED Curing Lights; DB686 HALO · Air Motors; CX235-3B, CX235-3C, CX235-3F · Dental Electrical Motors; C-PUMA MASTER · +8862025
Hangzhou SHINING3D Dental Technology Co., LtdChinaMakerCB11-A1 · CB11-A2 · CB11-A3 · CB11-A3.5 · +1562026
Ivoclar Vivadent, AGUnited StatesMakerCAD/CAM CEREC Starter Kit · IPS Build-Up Liquid · IPS Classic · IPS Classic Powder Opaquer · +326942026
BioHorizons Implant Systems, Inc.United StatesMakerACE SURIGICAL TRU-FIX IMPLANT SYSTEM · BioHorizons Dental Implant System · BioHorizons Internal Implant System · BioHorizons Laser-Lok 3 Implant System · +37412026
Kuraray Noritake Dental, Inc.JapanMakerCERABIEN · CERABIEN MiLai · CERABIEN ZR · CERABIEN ZR SS BASIC FULL KIT · +90322025
TruAbutment Inc.United StatesMakerTruAbutment DS · TruAbutment DS, TruBase · T-Marker SW172025
Cefla S.C.ItalyMakerEOS Compact · hyperion X5 · hyperion X9 pro · NewTom DCiS · +60152026
Genoray Co., Ltd.South KoreaMakerGenX-CR · GT300 · GT300-C · PAPAYA · +20142025
B.t.i. BiotechnologySpainMakerINPESPA1142024
Inter-Med, Inc.United StatesMakerBondsaver · Bondsaver D · Clean and Boost · Clean and Boost Gel · +16772026
Graphy, Inc.South KoreaMakerTERA HARZ · Tera Harz II · TERA HARZ DENTURE · Tera Harz Hard Denture · +362025
Dent4You AGSwitzerlandMakerBRILLIANT Bulk Fill Flow · BRILLIANT Crios · BRILLIANT EverGlow · BRILLIANT EverGlow Flow · +3352026
Chengdu Besmile Medical Technology Co., Ltd.ChinaMakerDental Glass Ceramics · Dental Porcelain Powder · Pre-Sintered Zirconia Coloring Liquid · Zirconia Dental Ceramics · +1552026
StrykerUnited StatesMakeradd name · Burr Hole covers · Custom Mandible Recon Plate · Delta DualStart · +48332024
Meta Biomed Co, LtdUnited StatesMakerADSEAL · ADSEAL Plus · CeraPutty · CeraSeal · +31242024
Liaoning Upcera Co., LtdChinaMakerCeramic Etchant (HF-5 and HF-9) · Dental Lithium Disilicate Glass Ceramic Block (Up. Press Series and Up. CAD Series) · DUO,Aevra · Glaze Paste, Glaze Powder, and Glaze Liquid · +10102026
Dental Direkt GmbHGermanyMakerDD Art Elements · DD Basic Shade · DD Bio ZW iso · DD Bio ZX² · +1992024
Shandong Huge Dental Material CorporationChinaMakerBioTemps NOW Milling Blocks · Denture Base · Denture Base Polymers · Flexible Block · +4382026
Noris Medical Ltd.IsraelMaker—82025
Paltop Advanced Dental Solutions Inc.United StatesMakerAdvanced + Dental Implant System · Advanced + Dia 3.25mm Dental Implant System · Advanced + NP Dental System · Advanced Dia 3.25mm Dental Implant System · +21272025
MICRO-NX Co., Ltd.South KoreaMakerChoice 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) · +2172025
Deltamed GmbHGermanyMakerBrush & Sculpt™ · CosmeCore™ · Creative Color® Clear Liquid Resin · Creative Color® Opaquer · +5262024
Paragon Implant Mfg., LLCUnited StatesMakerGEN5 and GEN5+ 3.3mm Implants · GEN5 Implants and Prosthetics · GEN5+ Implants and Prosthetics · NizLoc · +1642026
S.i.n. - Sistema de Implante Nacional S.A.BrazilMakerS.I.N. Dental Implant System · Sistema de Implante Nacional (S. I. N.) Dental Implant System · Cheek Retractor · BioHorizons · +142025
LuxCreo Inc.United StatesMakerLuxCreo Clear Aligner System · LuxCreo Clear Retainer System · LuxCreo Dental Clear Aligner Resin · FPD Reisn · +142026
Qpix Solutions, Inc.United StatesMakerEzSensor HD (IOS-U10IF) · EzSensor HD (IOS-U15IF) · EzSensor HD (IOS-U20IF, IOS-U15IF, IOS-U10IF) · EzSensor HD (IOS-U20IF) · +142026
Saremco Dental AGSwitzerlandMakerels extra low shrinkage® composite · saremco print Crowntec · els unibond42025
American OrthodonticsUnited StatesMakerBracePaste · Bracepaste - Color Change · BracePaste Band And Build LC · BracePaste Fluoride Sealant · +202442026
Premier Dental Products CompanyUnited StatesMakerCompCore AF · MultiMatch · MultiMatch Flow Chameleon AntiMicrobial Composite · Premier IntegraBond · +104282026
Implant DirectUnited StatesMakerCustom Legacy and Custom InterActive Titanium Abutments · InterActive SMARTBase Abutments · InterActive/SwishPlus2 Implant System · K060063 · +23242023
Young Innovations IncUnited StatesMakerImplant Prosthetic Components · Preat · Preat Abutments · PreatLoc · +229232025
Blue Sky Bio, LLCUnited StatesMakerBlue Sky Bio · Blue Sky Bio Dental Implant System · Blue Sky Bio Dental Implant System - Bio / Conus · Blue Sky Bio Dental Implant System - Double Hex 3 Platform · +19202024
Saeshin Precision Co., Ltd.South KoreaMakerACL(B)-61I, ACL(B)-62I, ACL(B)-63I, ACL(B)-65I, ACL(B)-04C · AHP-85-SS · DENTIS DIP20 · MEARA; MEAHP · +21162026
Kettenbach GmbH & Co. KGGermanyMakerFutar (Futar, Futar D, · Futar D Fast, Futar D Slow, · Futar Scan) Bite Registration · Identium Heavy · +30142026
Mectron S.P.A.ItalyMakercombi touch · COMPACT PIEZO LED · Compact Piezo P2K - Powercare · K10 · +20112025
Sdi LimitedAustraliaMakerEverfix · riva · Riva Bond LC · Riva Cem Automix · +7982022
Park Dental Research CorpUnited StatesMakerLEW Mini O-Ball Implant · STARTANIUS DENTAL IMPLANT SYSTEM · StarVent Internal Hex Screw Implant · StarVent Internal Hex Screw Implant Abutments · +2982026
Shinhung Mst Co., Ltd.South KoreaMakerMagDen Implant System · SI · SM · ST · +71472023
Keystone Dental Inc.United StatesMakerArcitexture Surface Technology · Co Axis · Co-Axis Implant · Endosseous Dental Implant System · +8772024
X-NAV Technologies, LLC.United StatesMakerEDX Bone Screw · EDX Tracker Arm · IconiX · IconiX AI · +1162026
Digimed Co., Ltd.South KoreaMakerDhx-70h · DIOX-602 · Hybrid C70 · HYBRID Pro · +762023
Jdentalcare SrlItalyMakerAbutment JDEvolution S · Abutment JDIcon · Abutment JDIcon Ultra S · Anatomic Abutment Angulated 15 H 1.5 JDEvolution Plus · +66052025
Guangdong JINME Medical Technology Co., Ltd.ChinaMakerDental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) · Dental High-Speed Turbine Handpiece (Model: T, S, TU, SU, TP, SP, TUQ, TUP, SUP, SUQ, TUQP, SUQP) · Dental Low-Speed Turbine Handpiece (Model: LN, L) · Surgical Drive System (model: ES70, ES90, E8) · +1052026
Harvest Dental Products, LLCUnited StatesMakerEasyGum Composite Strip · Poly Cast · PolyGum · PolySplint · +352023
PURGO BIOLOGICS Inc.South KoreaMakerTHE Graft · THE Graft Collagen · CYTOSHIELD · OpenTex · +252024
Changzhou Sifary Medical Technology Co., Ltd.ChinaMakerHand-held Dental X-ray System (HyperLight-M) · HyperLight Portable X-ray Unit · HyperLight Pro Portable X-ray Unit · Surgical Headlight, Wireless Z, Lux-SFT, Wireless Z+ · +2042026
Imagine Milling Technologies, LLCUnited StatesMakerALLONUS Tech Prosthetics · Customized Abutment · DESS Dental Smart Solutions · Geo Abutment · +1742026
Open ImplantsUnited StatesMakerNeodent Grand Morse · Sherlock Abutment · Sherlock Accessories42025
ADIN DENTAL IMPLANT SYSTEMS LtdIsraelMakerAdin Dental Implants System · Adin Short Implants · ADIN UNIFIT DENTAL IMPLANT SYSTEM · Anatomic Abutments · +10532026
Guilin Kevin Peter Technology Co., Ltd.ChinaMakerCalcium Hydroxide Temporary Filling Material (KP-Cal ) · Injectable Root Canal Sealer (KP-Root SP) · Flowable Restorative Material(KP-Flow LF, KP-Flow MF, KP-Flow HF) · 3D Printing Resin · +1432026
Vivos Therapeutics, Inc.United StatesMakerDNA · Vivos EMA Now · Vivos mmRNA Appliance · Vivos mRNA Appliance · +1132024
3Shape TriosDenmarkMakerL1P-1F · Trios 5 (L1P-1F) · Trios Ready Tip · S1P-2 scanning tip · +1132026
Zentek Medical LLCUnited StatesMakerBonafix · Bonafix 2 Plus · Bonafix Ti Base · Dentlot · +532025
Guangzhou Heygears IMC., Inc.ChinaMakerUltraPrint Denture UV · UltraPrint Flexible Denture UV · UltraPrint Temp C&B UV · UltraPrint Tray UV · +732026
Shenzhen Yurucheng Dental Materials Co., Ltd.ChinaMakerDental Glass Ceramics · Dental Lithium Disilicate Glass-Ceramics · Dental Zirconia Pre-shaded Block · GUSROM · +432023
Whitepeaks Dental Solutions GmbHGermanyMakerCopran Color · Copran Zr · CopraTemp · Copra Ti-2 · +432024
Fissiontech LLCUnited StatesMakerAdvanced Anti Snoring Device 4 Clear/ Advanced Anti Snoring Device 4 Blue · BestSelected Anti Snoring Device · Difiney Advanced Anti Snoring Device 4 · Difiney Anti Snoring Device · +132025
Good Sleep Co Pte LtdSingaporeMakerAvera · Hushd Pro Avera · HUSHD PRO Z-LINK · Z-LINK · +232025
Guilin Refine Medical Instrument Co., LTD.ChinaMakerExternal Oral Aerosol Suction System · Curing Light (Model: MaxCure9) · Portable Dental X-ray Device (Model: GT-1) · Dental Prophylaxis Powder, Model: PT-X1, PT-X2, PT-X3, PT-X6, PT-X5, PT-X7 · +232026
Shenzhen Xiangtong Co., Ltd.ChinaMakerColoring Liquid · Glass Ceramic · X-cera Pre-shaded Zirconia Blanks · X-Cera Zirconia Blanks · +232025
Yilink (Tianjin) Biotechnology Co., Ltd.ChinaMakerDental Glass-Ceramic Block · Dental porcelain powder · Dental Zirconia Ceramic Block · Glass Ceramics · +132024
Firstar Dental CompanyUnited StatesMakerFirstar Cabinet Mounted Dental Unit · Firstar Cart Mounted Dental Unit · Firstar Chair Mounted Dental Unit · Firstar Wall Mounted Dental Unit32026
Simda Co., Ltd.South KoreaMakerLab Analog · Scan Body · SIMDA Abutment32025
Yian Medical Technology (Haining) Co., Ltd.ChinaMakerDental CBCT X-ray System · OAS - X-ray, tomography, computed, dental32025
Bisco, Inc.United StatesMakerAELITE AESTHETIC ENAMEL · AELITE ALL-PURPOSE BODY · AELITE LS PACKABLE DENTIN · AELITE LS PACKABLE ENAMEL · +90882025
Parkell, IncUnited StatesMakerEtch-free · Smartemp · Resin post582025
Centrix, Inc.United StatesMakerEncore AF Natural W/Fluoride · Encore AF White w/Fluoride · Encore C-R Hybrid · Encore D/C · +29442025
Vericom Co., Ltd.South KoreaMakerDENFIL · DENFIL FLOW · SPACER · Vonflex Heavy, Vonflex Light · +8202026
Satelec - Acteon GroupUnited StatesMakerEDGESURGICALTIP - #1, #2, #3, #4, #5, #6 · EDGETIP - #1, #2, #3, #4, #5, #6, #7, #8 · Endo Tips - ETBD, ET18D, ET20D, ET40D, ET25S, ET25, ET25L · EndoCenter · +86182024
Neobiotech Co., Ltd.South KoreaMakerCMI implant EB System · CMI Implant IS II active · CMI IMPLANT IS SYSTEM · CMI implant IT System · +318172024
InnoBioSurg Co.,LtdSouth KoreaMakerAMII Implant Closing Screw · AMII Implant Healing Cap · AMII Implant Healing Cap Screw · AMII Implant System · +174152022
Hager& Meisinger GmbHGermanyMakerDental Implant OKTAGON · Dental Implants OKTAGON Bone Level Tapered Design · myplant two Abutment · myplant two Ball Anchor · +117142025
Somnomed, Inc.United StatesMakerClassic · Classic Lingual-Less · Flex · Fusion Classic · +16112026
Dentscare LtdaBrazilMakerAllcem · Allcem Core · Allcem Veneer APS · Allcem Veneer Try-in · +41102024
Zirkonzahn SrlItalyMakerAquarell · Color Liquids · ICE Prettau · ICE Transluzent Plus · +2102023
Dentalez, Inc.United StatesMakerConcentrix MX Handpiece - 265630 · DentaLube II - 262539 · HiFlo Fiber Optic Swivel · LED Plug N Play Swivel Assembly · +9192026
PaloDEx Group OyFinlandMakerORTHOPANTOMOGRAPH OP 3D · Orthopantomograph OP 3D EX · Orthopantomograph™ OP 3D EX · Orthopantomograph OP 3D LX · +492024
Den-Mat Holdings, LLCUnited StatesMakerCerinate Shade Modification System · Core Paste · DenMat Bulk Fill · DenMat Tenure · +15082026
Lares ResearchUnited StatesMakerL5 557 ProStyle SF NSK SC · L5 557 ProStyle SF NSK SLC · L5 757 ProStyle SF NSK SC · L5 757 ProStyle SF NSK SLC · +7482022
Vita Zahnfabrik H. Rauter GmbH & Co. Kg.GermanyMakerCelay Blanks Celay Optimizer · Hi-Ceram · In-Ceram AL Cube · In-Ceram Alumina · +4282026
Innovative Bioceramix, Inc.CanadaMakerEdgeBioceramic RetroFill and Perforation Repair Material .5g · EdgeBioceramic Sealer 2g · EdgeBioceramic ThermalFlow 1.5g · EndoSequence BC Pediatric Putty .5g 1P · +1982023
Vertex-Dental B.V.NetherlandsMakerCastapress · Castavaria · Ceramill Denture 3D+ · Hot Curing 20 Min Type C · +3272024
Handpiece HeadquartersUnited StatesMakerDental Handpiece Cleaner and Lubricant · DHR · HHC · Medidenta Air King · +1972024
Biotem Co., Ltd.South KoreaMakerAR_N SLA Type Implant System · AR_N Type Implant System · Bone Level Fixture · BR SLA Type Implant System · +3862023
Durr Dental SEGermanyMakerScanX Classic View · ScanX Edge · ScanX Intraoral View · ScanX Swift 2 · +2962023
Ttbio Corp.TaiwanMakerECO 105, ECO 101 4T4, ECO 101 4M4 · EVO 450 M4 · EVO 450, EVO 450L, EVO 450K, EVO 450KL, EVO 450N, EVO 450NL, EVO 450S, EVO 450SL, EVO 450ST, EVO 450STL · EVO 450W, EVO 450WL, EVO 450B, EVO 450BL, EVO 450MW, EVO 450MWL, EVO 450MR, EVO 450MRL · +2062023
Hass Corp.South KoreaMakerAmber LiSi-POM Series · Amber LiSi-POZ Series · Amber Mill Meso · Amber Mill Q Series & Amber Mill Direct Series · +662026
Dentca, Inc.United StatesMakerDENTCA Base Hi-Impact · DENTCA Base Premium · DENTCA Denture Base II/DENTCA Try-In · DENTCA Crown and Bridge · +462026
Pac-Dent Inc.United StatesMakerOptiComp · RapidCeram · Rodin 3D Ceramic Nanohybrid Resin · Rodin Sculpture 2 · +5752022
Imicryl Dis Malzemeleri Sanayi VE Ticaret ASTürkiyeMakerNova Compo C, Nova Compo MHC, Nova Compo HS, Balo, Swarpe · Nova Compo HF, Othocompo, Luxera, Maritza · Nova Compo N, Nova Compo SF, Nova Compo O, Nova Compo C · Nova Compomer (Classic and Rainbow) · +3852022
Materialise NVBelgiumMakerProPlan CMF Guides · SurgiCase CMF Guides · TruMatch CMF Ti 3D-Printed Implants · TruMatch CMF Ti 3D-Printed Plates · +1052026
SIC invent AGSwitzerlandMaker951378 · 951416 · 951417 · 951422 · +952026
WARANTEC Co., Ltd.South KoreaMakerFIU36085 · FIU36100 · FIU36115 · FIU36130 · +1,39642023
SmylioUnited StatesMakerAirFlex Aligners · FXBright Aligner · FXClear Aligner · NiTime Aligners · +742026
MedCADUnited StatesMakerAccuPlan System 3DTi · AccuPlate · AccuPlate 3DTi Patient-Specific Plating System · AccuPlate Patient-Specific Plate42023
Saliwell Ltd.IsraelMakerSaliPen42023
Alliage S/A Industrias Medico OdontologicaBrazilMakerD700 SLIM · EAGLE S · EVOLVE SENSOR · Portable Dental X-Ray · +11532024
DMP Dental Industry S.A.GreeceMakerBRIGHT FLOW CORE · BRIGHT LIGHT · BRIGHT LIGHT FLOW · BRIGHT POSTERIOR · +3532026
Yamahachi Dental Mfg. Co.JapanMakerBasis · BASIS FLOW II · Basis Hi · Basis Twin Cure · +2232026
ProSomnus Sleep TechnologiesUnited StatesMakerMicrO2 Sleep Device · Prosomnus [CA] Low Profile Sleep and snore Device with Compliance Monitoring · Prosomnus [IA] Sleep Device · Prosomnus [PH] Sleep and Snore Device · +1032026
Elevate Oral CareUnited StatesMakerFluoriMax · PapaCarie Duo · Advantage Arrest · Advantage Arrest Gel · +332024
Signifier Medical Technologies LimitedUnited KingdomMakereXciteOSA · eXciteOSA control unit only pack (warranty replacement) (17000) · eXciteOSA full system - with remote control (18010) · eXciteOSA mouthpiece replacement (16000) · +332024
SigmaGraft, Inc.United StatesMakerInterOss · InterOss Collagen · Maxxeus · Maxxeus Dental Xenograft Particulates · +232023
TRI Dental Implants Int. AGSwitzerlandMakerTRI Dental Implant System · TRI Matrix X-Force · TRI-matrix Implant Line · TRI Dental Implant Systems Instruments and Accessories32025
ClaroNav Inc.CanadaMakerNavident · MicronMapper · MicronMapper EVO · TissueMapper32024
DENTALMAX Co., LtdSouth KoreaMakerLUXEN 5G · LUXEN CL Dental Liquid · LUXEN Smile · LUXEN Zr32024
LightForce Orthodontics, IncUnited StatesMakerLightForce Orthodontic System · Signature Orthodontics · LightBracket32023
Perimetrics, IncUnited StatesMakerInnerView System32025
Keystone IndustriesUnited StatesMakerClearmet · Dentusil · Diamond D Denture Material · Duz-All · +11522025
Detax GmbHGermanyMakerFreepint denture impact dark reddish pink 1000g · freeprint denture flex pink 1000g · freeprint denture flex pink transparent 1000g · FREEPRINT® denture impact pink 1000 g · +4922025
SNUCONE Co., LTD.South KoreaMakerSNUCONE BONE LEVEL IMPLANT SYSTEM · SNUCONE TISSUE LEVEL IMPLANT SYSTEM · BONE FLATTENER · BONE TRIMMER · +7322023
Ditron Dental LtdIsraelMakerAbutment multi post screw, Multi-unit abutment screw, Multi-unit prosthetic screw. · Abutment, Implant, Dental Endosseous · Accelx cover screws · Accelx dental implants · +4122024
The Belport Company, Inc. DBA Gingi-PakUnited StatesMakerCeramic Hybrid Resin · OptiFlow II · Rodin Titan 3d Resin · 23985, Rodin Titan, Shade 0M3, 1.2kg/Bottle · +2022026
ZEROS Co., Ltd.South KoreaMakerIOS Abutment · STERI-OSS Implant System · ZEROS Dental Implant System · Abutment Lab Analog · +3622026
Oneday Biotech Co., Ltd.South KoreaMakerI DO IMPLAMT · Oneday Biotech Implant · Oneday Mini Implant System · Oneday Implant Abutment · +3322024
Premium Plus (Dongguan) LimitedChinaMakerSaliva ejectors · Applicator tips · Flowable composite and etching gel tips · Composite syringe gun, composite syringe tips · +3022025
Lakong Medical Devices Co., Ltd.ChinaMakeradvanceCAM · Laguna 2, Mirage 2 dental chair with delivery unit operatory package · Handpiece, Metal Quick Disconnect · Fiber optic/Dental delivery unit · +2122026
HDI Inc.South KoreaMakerDENU Composite Resin · DENU Flow Resin · Denu Block-Out Resin · Denu Jig Handy · +1922022
Ningbo Runyes Medical Instrument Co., Ltd.ChinaMakerDiagnostic X-Ray Equipment MobileX R98 · Diagnostic X-Ray Equipment POCT22 · Diagnostic X-Ray Equipment RAY88(P) · Diagnostic X-Ray Equipment RAY98(P) · +2122026
Dental Imaging Technologies CorporationUnited StatesMakerNOMAD Pro 2 · NOMAD Pro 3 · DEXIS IXS Size 1 · DEXIS IXS Size 1 Intraoral Sensor · +2022026
Modern Dental Laboratory Co., Ltd.ChinaMakerAnti-Snoring Device · EMA Custom, EMA First Step · Emerald Herbst · Moses Appliance · +1322024
Beijing C-Root Dental Medical Devices Co., LTD.ChinaMakerC-Root BP · Injectable Root Canal Bioceramic Sealer · Disposable tips · C-Root Sodium Hypochlorite Solution (3%, 5%, 5.25%) · +722024
Formlabs Inc.United StatesMakerDental LT Clear V2 Resin · Dental LT Comfort Resin · Premium Teeth Resin · Custom Tray Resin · +522026
Hunan Vsmile Biotechnology Co.,LtdChinaMakerDental Glass Ceramics Blocks (HT, LT, MT) · Dithilicate Glass Block · Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank · Acetal Flexible PMMA Block · +522024
AsigaAustraliaMakerDentaTOOTH · DentaTRAY · DentaTRAY Orange · DentaBASE · +322025
Fussen Technology Co., LtdChinaMakerDental Computed Tomography X-ray System · Rubik XSmart · Digital Intraoral Imaging Plate System · Fussen, Digital Intraoral Scanner System S6000 · +322026
Bloomden Bioceramics (HuNan) Co.,Ltd.ChinaMakerBloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, MOD: 3D-Pro-ML, UT, UT-C, UT-ML, HTP-plus · Bloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, MOD: 3DP-Pro-ML, UTP, UTP-C, UTP-ML · Bloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, MOD: STP,STP-C,STP-ML,SHTP,SHTP-C,SHTP-ML · Bloomden, Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank, MOD:HT-plus,ST,ST-C,ST-ML,SHT,SHT-C,SHT-ML · +222026
Shenzhen Xpectvision Technology Co., Ltd.ChinaMakerIntraoral X-ray Sensor Holder, Model XVH001 · XpectVision, Handheld Dental X-ray System, XVbeam2000 · XVD2121 Plus · XVD2530 · +122024
Clemde SA DE CVMexicoMakerPF Keep / Cad Cam Peek Block · Partial Flex22025
Foshan Topmed Dental Co., Ltd.ChinaMakerDental air-motor handpiece(TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) · High speed air turbine handpiece (TM-T1B2, TM-T1M4, TM-T2B2, TM-T2M4, TM-T3B2, TM-T3M4, TM-T4B2, · TM-T4M4, TM-T6B2, TM-T6M4)22026
Graphenano Dental, SLSpainMakerG-CAM · GRAPHENANO DENTAL22025
Zhejiang Yinchili Medical Technology Co.,LtdChinaMakerClearCorrect System · Custom-made Invisible Aligners · REF04 ClearCorrect System Retainer, Clear Retainer (YCL-A-R, YCL-C-R) · REF06 ClearCorrect System Engager Template22023
newton implant systemsUnited StatesMakerimplant, endosseous, root-form · Ni2 Newton Implant Systems · accessories, implant, dental, endosseous22024
PICOPACK Inc.South KoreaMakerWeRay · MDP · WeSensor22024
Aiomega, LLCUnited StatesMakerAIO BREATHE22025
Enpuno Biotechnology Co., LtdChinaMakerInjectable Root Canal Bioceramic Sealer(nRoot SP),NR SP-0.5, NR SP-1, NR SP-2, NR SP-3, NR SP-5 · Root canal repair materials (nRoot BP)22025
MEDPARK.Co., Ltd.South KoreaMakerEndobon® Bovine Xenograft Moldable · Endobon® Bovine Xenograft Particulate22026
MGNEWTON Ltd.South KoreaMakerCURA-Temp · ELEC Master, ELEC Master Dual22023
Sincera Technology (changchun) Co., LtdChinaMakerLight Cure Composite · Light Cure Adhesive22024
Smart Denture Conversions, LLCUnited StatesMakerProsthetic Screw, Paltop (IHex)22026
Unidental Co., Ltd.South KoreaMakerUNIdental Symphony Implant System22026
Hunan Qinghao Puzhong Technology Co., Ltd.ChinaMakerDental Zirconia Blank22026
iRay Imaging Technology (Haining) LimitedChinaMakerCanis014D0722023
LAON MEDI Inc.South KoreaMakerLaon Ortho22025
Meticuly Co., Ltd.ThailandMakerMETICULY Patient-specific titanium maxillofacial mesh implant22026
Tns Co., Ltd.South KoreaMakerSerafin®22025
Infinitum Eta Ltd.IsraelMaker—22025
A-dec, Inc.United StatesMakerAir High Speed Handpieces · Air Low Speed Handpiece · Alegra · AM-20 MW · +153682022
Coltene/Whaledent AGSwitzerlandMakerBrilliant · BRILLIANT Bulk Fill Flow · BRILLIANT Crios · BRILLIANT EverGlow · +255452022
J. Morita USA, Inc.United StatesMakerCF Carbon Fiber Post · GF Glass Fiber Post · MORITA DISPOSABLE DENTAL NEEDLE · FormCore DC Core Build-up Material · +9422022
Osteomed, LLCUnited StatesMakerDental Burs262022
Planmeca OyFinlandMakerPlanmeca ProMax · Planmeca ProMax 3D · Planmeca ProMax 3D Mid · Planmeca ProMax 3D Plus · +14252023
Dentium USAUnited StatesMakerAAB154515H · AAB154515HE · AAB154515HL · AAB154515HT · +1,570232022
Collagen Matrix, Inc.United StatesMakerMatrixDerm CAP Regenerative Collagen Dental Membrane · MatrixDerm EXT Regenerative Collagen Dental Membrane · MatrixDerm Regenerative Collagen Dental Membrane · Matrixflex · +15202024
W&H Dentalwerk Buermoos GmbHAustriaMaker—172026
Essential Dental Systems, Inc.United StatesMakerBelixa Injectable, Belixa Bulk Fill · Ti-Core · Ti-Core Natural · CEMPOWER · +24152023
DIO CorporationSouth KoreaMakerDIO Ball Cap · DIO Dental Implant System · Dio Protem Implant System · DIO Retainer · +508142023
KJ Meditech Co., Ltd.South KoreaMakerAnchor plus · Conical Plus Implant System · HERO I DENTAL IMPLANT SYSTEM · HERO II DENTAL IMPLANT SYSTEM · +27132022
The Argen CorporationUnited StatesMakerArgenIS · ArgenIS Angled Screw Channel (ASC) Titanium Blanks · ArgenIS Angled Screw Channel (ASC) Titanium Screws · ArgenIS Titanium Abutments · +1,363112024
Beijing Naton Technology Group Co. Ltd.ChinaMakerInion CPS 1.5/2/2.5 Bioabsorbable Fixation System · Inion CPS Baby 1.5 Bioabsorbable Fixation System · Inion CPS Baby Biodegradable Fixation System · Inion CPS Biodegradable Fixation System · +7102025
Neoss ABSwedenMakerNeoss Individual Prosthetics · 1- 6mm Locator Abutment for Neoss 4.1mmD Implant · NeoGen Collagen Firm · NeoGen Collagen Flex · +9102022
Siesta Medical, Inc.United StatesMakerEncore System102021
Jeil Medical CorporationSouth KoreaMakerBone Fixation Screw Kit · GBR System · JEIL BONE FIXATION SYSTEM · Leforte MMF System · +4092026
Soadco, S.L.AndorraMakerKLOCKNER ABUTMENTS · Klockner Dental Implant Abutments · Klockner Dental Implant Abutments (II) · Klockner Vega Dental Implant System · +1492023
Cdb CorporationUnited StatesMakerCDB Clip · CDB Flip-Slide-Clip Bracket · Buttons · RELECTIONS · +392022
Ortho Organizers, Inc.United StatesMakerCervical Neck Pads · ClassOne Facemask · ClassOne Safety Release Modules · Extraoral Facebows · +38682025
MaruchiSouth KoreaMakerAH Plus® Bioceramic Sealer · CleaniCal · ENDOCEM MTA · ENDOCEM MTA PREMIXED REGULAR · +2182023
Midmark CorporationUnited StatesMakerMIDMARK · Midmark Dental Delivery System · Midmark Intraoral Digital Sensor · PROGENY IMAGING SOFTWARE · +1172025
Dreve Dentamid GmbHGermanyMakerDynax clear · Dynax heavy body · Dynax light · Dynax mono · +2362025
De Götzen S.R.L.ItalyMakerU-SENSE · U-SENSE HD · X-MIND optima · X-MIND optima 3D · +562023
Hdx Will Corp.South KoreaMakerDental X-ray system · DENTRI Max (DENTRI?, DENTRI-C?, DENTRI-S?) · DENTRI? series (DENTRI?, DENTRI-C?, DENTRI-S?) · DENTRIa series (DENTRIa, DENTRI-Ca, DENTRI-Sa) · +662021
Sleeping Well, LLCUnited StatesMakerZQuiet · ZQuiet Advance Anti-Snoring Mouthpiece · ZQuiet Pro-Flex · ZQuiet Pro-Plus · +262022
Biomaterials Korea, Inc.South KoreaMakerACR · Anchor Plate · OAS-T1809-SP · OAS-T1811-SP · +31152023
Tp Orthodontics, Inc.United StatesMakerClearVu · ClearVu with pre-applied adhesive · Click-It Self Ligating Bracket · InVu · +12452022
New Stetic, SAColombiaMakerDuracryl · EZ-Cryl · Fidelity · Novacryl · +3352026
Osstell ABSwedenMakerMega ISQ II · NeoTell · Osstell Beacon · Osstell Classic · +2452026
Trident SRLItalyMakerBlu · Blu size 2 · BOOM sensor · BOOM sensor size 2 · +1452023
Good Doctors Co., Ltd.South KoreaMakerCL-DC20 · CL-DC21 · CL-DP40 (Dr's Light CHOICE) · CL-DP40 (Dr's Light PRIME) · +1152023
Codent Technical Industry Co., Ltd.TaiwanMakerCODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS · CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES · High Speed Handpieces And Accessories · Fiber Optic Brushless Electronic Micromotor (iM100)52024
Rayence Co., Ltd.South KoreaMaker—52022
A.B. Dental Devices , Ltd.IsraelMakerA.B. DENTAL DEVICES Dental Implants System · AB Dental Devices Dental Implants · AB LOC H1mm Conical Platform · AB LOC H2mm Conical Platform · +62242026
Alpha-Bio TecIsraelMakerAbutment Screw - CS · Adhesive Coping for D3.5 MU · Angled Ti abutment 10 ° 1.5 CHC · Angled Ti abutment 10 ° 1.5 CS · +25642026
DMG Chemisch-Pharmazeutische Fabrik GmbHGermanyMakerContax Intro + Activator · Contax Intro + Activator USA · Contax-Activator Refill · Contax-Bond Refill · +26042022
Leone S.P.A.ItalyMakerLEONE EXPANDERS · Mandibular advancers · Thermoplastic material · Orthodontic headgear, facemask/bow · +2942025
Foshan Cicada Dental Instrument Co, Ltd.ChinaMakerDisposable/Dental Irrigation Needle, Disposable/Dental Irrigation Syringe, · Dental Electric Motor: NL 400-1,NL 400-2,NL 400-3, NL 400-4 · Curing Light, Broad Spectrum Curing Light, CV-215 G1--G8, 215i, 215i Plus, 216, 218, DTO · CV/GX644, CV/GX652, CV/GX654, GK01L, GK02L, GK03L, GK45L, GN02L, GN45L, GN01, G401, G402, G445, G406, G408, G409, G410, · +1042022
Dentmate Technology Co. , Ltd.TaiwanMakerLEDEX · LEDEX WL-070 Dental Curing Light · LEDEX WL-070+ ; LEDEX WL-070+ ORTHO · LEDEX WL-090 Dental Curing Light · +142022
uLab Systems, Inc.United StatesMakeruLab Systems Dental Aligner · ULab Systems UDesign · uLab Systesm uDesign IDB42022
Alpha Dent Implants GmbHGermanyMakerdental Implant " Implant Classic_" · Dental implant "Zahntium Implant" · DENTAL IMPLANT SUPERIOR ACTIVE-ISPA AND ACTIVE BIO PLUS -IABP · dental implants "Implant Active Bio_" · +8932024
BIO CONCEPT Co., LtdChinaMakerBLT Dental Implant System · BV Dental Implant System · Dental Implant System · Anchor Drill · +6632022
Amann Girrbach AGAustriaMakerCeramill HT+ PS · Ceramill HT+ white · Ceramill Liquid · Ceramill Liquid fx · +4132026
Garrison Dental Solutions LLCUnited StatesMakerA+ Wedge™ · ClearView · Composi-Tight® · G Wedge™ · +2132024
Myofunctional Research Co. Usa Inc.United StatesMakerBruxogard · Myobrace · Myoretainr · Myotalea · +832026
Dentium Co.,Ltd(ICT branch)South KoreaMakerbright CT · bright MCT · rainbow CT · rainbow MCT · +332023
3D Systems, Inc.United StatesMakerJaw in a Day · VSP Distraction · VSP Orthognathics · VSP Reconstruction · +232026
bredent GmbH & Co. KGGermanyMakervisio.lign color · visio.lign shield32024
True Function Laboratory IncUnited StatesMakerElastic Mandibular Advancement (EMA) · True Function Adjustable Herbst Appliances · TrueDorsal32026
Planmed OyFinlandMakerPlanmed Verity32022
KaVo Dental GmbHGermanyMaker0.535.5200 - INTRA-L-MOTOR 181 H · 0.535.5210 - INTRA L-LUX 181 L · 0.535.5250 - INTRAmatic 181 M · 0.535.5260 - INTRA 181 K 20 000 R.P.M. · +39822021
Surgikor, LLCUnited StatesMakerAbutment Screw · Anatomic Straight Abutment · Anti-Rotation Abutment · Ball Attachment Abutment · +35922024
Uniqa Dental, Ltd.IsraelMakerConical drills with external irrigation · Countersink, one size · Countersink, two sizes · Drill extender · +13722026
Sewon Medix, Inc.South KoreaMakerBIOTHREAD BT3 Implant System · IH Implant System · BONE TRIMMER (SBT50) · Drill & Drill Accessories (Guide Drill, Drill Extension, Twist Drill, Pilot Drill, Cortical Drill, Drill Stopper) · +9522023
NuSmile, Ltd.United StatesMakerAvalon Biomed Grey MTA Plus · Avalon Biomed NeoMTA 2 · Avalon Biomed NeoMTA Plus · Avalon Biomed NeoPUTTY · +8522026
DSI Dental Solutions LtdIsraelMakerSil-Flow · Unilite Flow · Unilite Flow Kit · Unilite Universal Composite · +3222025
Koncept Innovators, LLCUnited StatesMakerBright Guard Pro 2 · Dormiva Anti-Snoring Mouth Guard · Eliminator Pro 2 · Intelliguard Pro · +922026
DMAX Co., Ltd.South KoreaMakerADD-Z · Alpha+ · CAMeleon Coloring Liquid · Chang's Liquid · +1522025
Microware Precision Co., Ltd.TaiwanMakerBiomet Microfixation OmniMax MMF System · LORENZ 1MM, 1.5MM, 2MM SYSTEM · Tandry CMF Plate System · BIO-RAY A-1 Anchor Screw System · +1022022
Shinhung Company, Ltd.South KoreaMakerG7, Dental Operative Unit and Accessories · TAURUS C1 · K-irrigator tips · SHINJECT · +1022023
AIOBIO Co., Ltd.South KoreaMakerLINKDENS VU · Qrayview pro · MouthCAM Pro · Qraypen, Qraypen C · +322024
Biotech DentalFranceMakerKontact Dental Implant System · KontactTM Dental Implant System · Y-BRUSH · FIX'IN sel-drilling screw22022
Wuxi EA Medical Instruments Technologies LimitedChinaMakerAngel Aligner · Clear Aligner(EAB II) · Retainer · Removal tool · +322023

Showing 250 of 3,592 companies, makers and the most recently active first.

Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026