Latest FDA clearances for dental devices
12,836 dental 510(k) clearances since 1976. The newest decision in FDA's file is dated 30 Oct 2026.
Clearances per year, 1976–2026 · 199 so far in 2026
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 30 Oct 2026 | K263860 | Shining3D Clear Aligner System | Hangzhou SHINING3D Dental Technology Co., Ltd | NXC Sequential Aligner |
| 30 Oct 2026 | K262685 | Zirconia Collective 4Y Dental Zirconia Blank | Zirconia Collective, Inc. | EIH Porcelain Powder |
| 29 Oct 2026 | K262756 | Zirconia Dental Ceramics and Staining Solution | Fanen New Materials Technology (Suzhou) Co., Ltd. | EIH Porcelain Powder |
| 29 Oct 2026 | K262415 | OSSIX Plus | Datum Dental, Ltd. | NPL Intraoral Animal Source Barrier |
| 29 Oct 2026 | K260356 | EndoColibri | Koehrer Medical Engineering GmbH | NYL Root Canal Irrigation Air-Powered Handpiece |
| 27 Oct 2026 | K262775 | AquaVance Clear Fluoride Treatment | The Belport Company, Inc. DBA Gingi-Pak | LBH Cavity Varnish |
| 23 Oct 2026 | K260421 | LuxDesign | LuxCreo Inc. | PNN Orthodontic Software |
| 23 Oct 2026 | K260275 | Mobile Dental Solution (Model: DS50, DS70, DS90) | Guangdong JINME Medical Technology Co., Ltd. | EIA Operative Dental Unit |
| 22 Oct 2026 | K261295 | MultiNeO Dental Implant System | Alpha-Bio Tec | DZE Root-Form Endosseous Implant |
| 21 Oct 2026 | K262980 | INNI-CERA (BCM-W500, BCM-W1000) | DentMedi Co., Ltd. | EIH Porcelain Powder |
| 20 Oct 2026 | K262937 | PDR Airway Device | Park Dental Research Corp | LRK Anti-Snoring Device |
| 20 Oct 2026 | K262421 | Daybreak Impression Material | Sleepcare, LLC | SHI Over-the-Counter Impression Material for Fabrication of Patient-Matched Mouthguards |
| 16 Oct 2026 | K262523 | Amber Arte | Hass Corp. | EIH Porcelain Powder |
| 16 Oct 2026 | K262478 | BCS Bioceramic Sealer | BCS Device Pte., Ltd. | KIF Root Canal Filling Resin |
| 13 Oct 2026 | K262433 | OrthoFit Aligner (OrthoFit Aligner A2) | Spident Co., Ltd. | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 13 Oct 2026 | K261321 | Yomi S Robotic System | Neocis | QRY Dental Navigation System |
| 9 Oct 2026 | K260913 | CMF Titanium Splints | Materialise NV | DZJ Manual Wire Driver and Bone Drill |
| 9 Oct 2026 | K260096 | Wishbone HAE | Wishbone | NPM Animal Source Bone Grafting Material |
| 8 Oct 2026 | K263680 | One Coat Bond; One Coat Bond SL | Dent4You AG | KLE Resin Tooth Bonding Agent |
| 7 Oct 2026 | K262378 | Dr.AlignNavi | InnoDtech, Inc. | PNN Orthodontic Software |
| 6 Oct 2026 | K260136 | Forza | True Function Laboratory Inc | LRK Anti-Snoring Device |
| 1 Oct 2026 | K260029 | Firstar Dental Handpieces | Firstar Dental Company | EFB Dental Air-Powered Handpiece |
| 1 Oct 2026 | K260027 | Firstar Dental Electric Motor | Firstar Dental Company | EBW Handpiece and Cord Foot Controller |
| 30 Sep 2026 | K263033 | Dental Computed Tomography X-ray System (Rubik XSmart, Rubik X1, Rubik X3) (Matrix 7000, Matrix 7800) | Fussen Technology Co., Ltd | OAS Dental Computed Tomography X-Ray |
| 30 Sep 2026 | K261663 | EzSensor HD | Qpix Solutions, Inc. | MUH Digital Extraoral Source X-Ray System |
| 30 Sep 2026 | K261327 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | NHA Endosseous Dental Implant Abutment |
| 25 Sep 2026 | K262983 | EsTemp Implant | Spident Co., Ltd. | EMA Dental Cement |
| 25 Sep 2026 | K262196 | Invisalign System | Align Technology, Inc. | PNN Orthodontic Software |
| 25 Sep 2026 | K254210 | REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) | HYUNDAI BIOLAND Co., Ltd. | NPM Animal Source Bone Grafting Material |
| 24 Sep 2026 | K262252 | MPa Max adhesive | Den-Mat Holdings, LLC | KLE Resin Tooth Bonding Agent |
| 23 Sep 2026 | K262207 | Cemented Plus Abutment | Unidental Co., Ltd. | NHA Endosseous Dental Implant Abutment |
| 23 Sep 2026 | K262144 | DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece | Setagaya Seiki Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 21 Sep 2026 | K262982 | Core·it Dual | Spident Co., Ltd. | EBF Resin Tooth Shade Material |
| 21 Sep 2026 | K260940 | BellaTek Bars | ZimVie US Corp LLC | NHA Endosseous Dental Implant Abutment |
| 17 Sep 2026 | K261392 | TriActive Dental Implant System | Paragon Implant Mfg., LLC | DZE Root-Form Endosseous Implant |
| 16 Sep 2026 | K261888 | ClearClub Impression Material | ClearClub | SHI Over-the-Counter Impression Material for Fabrication of Patient-Matched Mouthguards |
| 16 Sep 2026 | K254152 | Dia-X Sil Light Body | DiaDent Group International | ELW Impression Material |
| 16 Sep 2026 | K254142 | Dia-X Sil Heavy Body | DiaDent Group International | ELW Impression Material |
| 14 Sep 2026 | K260795 | Hand-held Dental X-ray System (HyperLight-M) | Changzhou Sifary Medical Technology Co., Ltd. | EHD Extraoral with Timer X-Ray Unit |
| 11 Sep 2026 | K262050 | Vioseal X | Spident Co., Ltd. | KIF Root Canal Filling Resin |
| 10 Sep 2026 | K262202 | Cerasmart Forte | GC America Inc. | EBF Resin Tooth Shade Material |
| 10 Sep 2026 | K254009 | Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV) | Lakong Medical Devices Co., Ltd. | SJH Portable Dental Operative Unit |
| 8 Sep 2026 | K261987 | Reusable SmartPeg | Osstell AB | EKX Ac-Powered Direct Drive Handpiece |
| 4 Sep 2026 | K253909 | NeoPEX Pre-Mixed Obturation Paste | NuSmile, Ltd. | KIF Root Canal Filling Resin |
| 3 Sep 2026 | K262243 | Profisil Free | Kettenbach GmbH & Co. KG | LBH Cavity Varnish |
| 31 Aug 2026 | K261695 | Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) | Guilin Kevin Peter Technology Co., Ltd. | EBF Resin Tooth Shade Material |
| 28 Aug 2026 | K253954 | X-Guide Surgical Navigation System | X-NAV Technologies, LLC. | QRY Dental Navigation System |
| 27 Aug 2026 | K262104 | Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT) | Ram.Shaw Pte., Ltd. | LRK Anti-Snoring Device |
| 27 Aug 2026 | K261802 | Glidewell Denture Base Resin | Prismatik Dentalcraft, Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 25 Aug 2026 | K261514 | Calcium Hydroxide Temporary Filling Material (KP-Cal) | Guilin Kevin Peter Technology Co., Ltd. | KIF Root Canal Filling Resin |
| 25 Aug 2026 | K254304 | iNOS intraoral biosensor | Achaemenid, LLC | PLC Sleep Appliances with Patient Monitoring |
| 24 Aug 2026 | K254286 | Guided Bone Regeneration System | DentalMaster (Xiamen) Medical Technology Co., Ltd. | DZL Intraosseous Fixation Screw |
| 21 Aug 2026 | K262074 | Any-Zircos | Mediclus Co., Ltd | EIH Porcelain Powder |
| 19 Aug 2026 | K260463 | ZEROS Dental Implant System | ZEROS Co., Ltd. | DZE Root-Form Endosseous Implant |
| 17 Aug 2026 | K260137 | KLS Martin IPS Oral-Max Implants - MR Conditional; Individual Patient Solutions - Ti (IPS-Ti); Individual Patient Solutions - PEEK (IPS-PEEK); KLS Martin Individual Patient Solutions | KLS Martin SE & Co. KG | JEY Bone Plate |
| 13 Aug 2026 | K261626 | UltraPrint Flexible Denture UV | Guangzhou Heygears IMC., Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 13 Aug 2026 | K254201 | Any-Cem | Mediclus Co., Ltd | EMA Dental Cement |
| 7 Aug 2026 | K261937 | PacTemp Automix NE | The Belport Company, Inc. DBA Gingi-Pak | EMA Dental Cement |
| 7 Aug 2026 | K251544 | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) | Lakong Medical Devices Co., Ltd. | EIA Operative Dental Unit |
| 6 Aug 2026 | K253999 | Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment Engaging and Non-Engaging; Healing Abutment Conical Connection; Omnigrip Clinical Screw Titanium; Omnigrip Prosthetic Screw | Nobel Biocare Services AG | NHA Endosseous Dental Implant Abutment |
| 5 Aug 2026 | K261456 | Ruthinium Disc | Dental Manufacturing S.p.A. | POW Resin Long-Term Temporary Crown and Bridge |
| 31 Jul 2026 | K262681 | NanoCeram Resin | 3BFAB Teknoloji AS | EBI Rebasing Repairing Relining Denture Resin |
| 31 Jul 2026 | K261912 | SnØreNegatØr | DnB Innovations, LLC | LRK Anti-Snoring Device |
| 31 Jul 2026 | K253655 | Angled Screwdriver MED (M-SD090) | W&H Dentalwerk Bürmoos GmbH | DZI Powered Bone Drill |
| 30 Jul 2026 | K262239 | Obsidian® Press Over Zirconia | Prismatik Dentalcraft, Inc. | EIH Porcelain Powder |
| 25 Jul 2026 | K253206 | METICULY Patient-specific CMF solution | Meticuly Co., Ltd. | JEY Bone Plate |
| 23 Jul 2026 | K261748 | Dental Cone-beam Computed Tomography (mDX-15P Series) | Hefei Meyer Optoelectronic Technology Inc. | OAS Dental Computed Tomography X-Ray |
| 21 Jul 2026 | K261728 | One-Fil LC | Mediclus Co., Ltd | EJK Calcium Hydroxide Cavity Liner |
| 17 Jul 2026 | K261046 | Dental Zirconia Blank & Coloring Liquid | Hunan Qinghao Puzhong Technology Co., Ltd. | EIH Porcelain Powder |
| 9 Jul 2026 | K261166 | DIA-CEM | DiaDent Group International | EMA Dental Cement |
| 8 Jul 2026 | K262300 | Denture Base Resin V2 | Formlabs Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 6 Jul 2026 | K253317 | Cytrans Elashield | GC America Inc. | LYC Synthetic Bone Grafting Material |
| 2 Jul 2026 | K261847 | iTero Lumina Pro | Align Technology, Inc. | NTK Light Transmission Caries Detector |
| 2 Jul 2026 | K261129 | OrthoFit | Spident Co., Ltd. | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 2 Jul 2026 | K260527 | FACE4D Aligner | Avinent Implant System S.L.U. | NXC Sequential Aligner |
| 1 Jul 2026 | K262228 | Transcend Bulk Fill Flowable Composite | Ultradent Products, Inc. | EBF Resin Tooth Shade Material |
| 1 Jul 2026 | K261485 | Tetric plus Fill;Tetric plus Flow | Ivoclar Vivadent, AG | EBF Resin Tooth Shade Material |
| 1 Jul 2026 | K261474 | DENTCA Tru Flexible | Dentca, Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 1 Jul 2026 | K261147 | Neodent Implant System - NeoConvert Fit | Institut Straumann AG | NHA Endosseous Dental Implant Abutment |
| 30 Jun 2026 | K262195 | Dandy Ceramic Stain and Glaze | Zima International Inc., dba Dandy | EIH Porcelain Powder |
| 29 Jun 2026 | K261415 | Injectable Root Canal Sealer (KP-Root SP) | Guilin Kevin Peter Technology Co., Ltd. | KIF Root Canal Filling Resin |
| 29 Jun 2026 | K260918 | Zolid Lunaris | Amann Girrbach AG | EIH Porcelain Powder |
| 27 Jun 2026 | K261122 | MIST IC | Imagine Milling Technologies, LLC | NHA Endosseous Dental Implant Abutment |
| 26 Jun 2026 | K260061 | BioHorizons CEREC Compatible Ti-Bases | BioHorizons Implant Systems, Inc. | NHA Endosseous Dental Implant Abutment |
| 25 Jun 2026 | K251188 | UNIQA® Dental Implants System | Uniqa Dental, Ltd. | DZE Root-Form Endosseous Implant |
| 18 Jun 2026 | K261246 | SRGC-06 | GC America Inc. | EBF Resin Tooth Shade Material |
| 18 Jun 2026 | K253776 | Implantmed Plus II & Piezomed Plus II Module | W&H Dentalwerk Buermoos GmbH | DZI Powered Bone Drill |
| 18 Jun 2026 | K253131 | Curing Light (M-Cure 6) | Guangzhou Rebornendo Medical Instrument Co., Ltd. | EBZ Ultraviolet Activator for Polymerization |
| 18 Jun 2026 | K251232 | MegaGen Zygoma Dental Implant System | Megagen Implant Co., Ltd. | DZE Root-Form Endosseous Implant |
| 18 Jun 2026 | K250806 | Dental Implant System | A.B. Dental Devices , Ltd. | DZE Root-Form Endosseous Implant |
| 17 Jun 2026 | K260006 | INOSS System | Inosys, Inc. | DZE Root-Form Endosseous Implant |
| 16 Jun 2026 | K253723 | BOSS | MEDPARK.Co., Ltd. | NPM Animal Source Bone Grafting Material |
| 15 Jun 2026 | K253922 | Neodent Scannable Healing Abutment | Institut Straumann AG | NHA Endosseous Dental Implant Abutment |
| 12 Jun 2026 | K261366 | Virtus | Somnomed, Inc. | LRK Anti-Snoring Device |
| 11 Jun 2026 | K261251 | Snorbliss® Anti-Snoring Device | Endeavor Commerce, LLC | LRK Anti-Snoring Device |
| 11 Jun 2026 | K260859 | Rosetta SM, Rosetta SP | Hass Corp. | EIH Porcelain Powder |
| 11 Jun 2026 | K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut) | Smart Denture Conversions, LLC | NHA Endosseous Dental Implant Abutment |
| 11 Jun 2026 | K253052 | Fluoride Varnish (Type A,Type C) | Nagy Oral Technology Qinhuangdao Co., Ltd. | LBH Cavity Varnish |
| 11 Jun 2026 | K250839 | Dental X-ray System | Changzhou Boen Zhongding Medical Technology Co., Ltd. | OAS Dental Computed Tomography X-Ray |
| 9 Jun 2026 | K260564 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 4 Jun 2026 | K260662 | Dental Cone Beam Computed Tomography System | Yofo Medical Technology Co., Ltd. | OAS Dental Computed Tomography X-Ray |
| 3 Jun 2026 | K261840 | BracePaste Prime Plus | American Orthodontics | DYH Resin Bracket and Tooth Conditioner Adhesive |
| 3 Jun 2026 | K261826 | VSP System (Titanium Palatal Splint) | 3D Systems, Inc. | DZJ Manual Wire Driver and Bone Drill |
| 3 Jun 2026 | K252904 | SIC Abutments including CAD/CAM Solutions | SIC invent AG | NHA Endosseous Dental Implant Abutment |
| 2 Jun 2026 | K261093 | DIAFIL | DiaDent Group International | EBF Resin Tooth Shade Material |
| 2 Jun 2026 | K260569 | DB 4000 High Impact Denture Base | Carbon, Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 27 May 2026 | K260367 | Portable Dental X-ray System Model PDX nova | PDX Co., Ltd. | EHD Extraoral with Timer X-Ray Unit |
| 21 May 2026 | K253191 | DCMhotbond zircon | Dental Creativ Management GmbH | EIH Porcelain Powder |
| 20 May 2026 | K253774 | Elos Accurate® Denture Fixation System | Elos Medtech Pinol A/S | NHA Endosseous Dental Implant Abutment |
| 19 May 2026 | K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) | DiaDent Group International | EBF Resin Tooth Shade Material |
| 19 May 2026 | K260268 | OrthoEasy Pal; OrthoEasy Pal Long Neck | Bernhard Förster GmbH (Bernhard Foerster Ltd.) | OAT Orthodontic Endosseous Implant |
| 18 May 2026 | K254109 | G-CEM UNIVERSAL | GC America Inc. | EMA Dental Cement |
| 15 May 2026 | K253935 | medXion NEXUS | medXion Technologies, Inc. | OAS Dental Computed Tomography X-Ray |
| 14 May 2026 | K261134 | Dormiva Anti-Snoring Mouth Guard | Koncept Innovators, LLC | LRK Anti-Snoring Device |
| 14 May 2026 | K260485 | Any-Etch | Mediclus Co., Ltd | KLE Resin Tooth Bonding Agent |
| 14 May 2026 | K253883 | Bonalive Maxillofacial | Bonalive Ltd | LYC Synthetic Bone Grafting Material |
| 14 May 2026 | K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments | Hiossen Inc. | NHA Endosseous Dental Implant Abutment |
| 12 May 2026 | K252731 | Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant | Promimic AB | DZE Root-Form Endosseous Implant |
| 11 May 2026 | K260805 | Dual Core | Vericom Co., Ltd. | EBF Resin Tooth Shade Material |
| 8 May 2026 | K260788 | Smylio Aligners | Smylio | NXC Sequential Aligner |
| 8 May 2026 | K260419 | LingOral Dental Design System | Hangzhou ChohoTech Co., Ltd | PNN Orthodontic Software |
| 7 May 2026 | K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue | Institut Straumann AG | NHA Endosseous Dental Implant Abutment |
| 6 May 2026 | K260376 | Denture Base | Shandong Huge Dental Material Corporation | EBI Rebasing Repairing Relining Denture Resin |
| 1 May 2026 | K260819 | Any-Com Seal | Mediclus Co., Ltd | EBC Pit and Fissure Sealant and Conditioner |
| 1 May 2026 | K252073 | VOCO Profluorid Varnish + BioMin | Voco GmbH | LBH Cavity Varnish |
| 30 Apr 2026 | K261404 | UltraEZ | Ultradent Products, Inc. | LBH Cavity Varnish |
| 28 Apr 2026 | K252464 | Surgical Microscope (OMS2360, OMS2380) | Zumax Medical Co., Ltd. | NBL Light-Induced Fluorescence Caries Detector |
| 27 Apr 2026 | K261357 | Grandio disc multicolor | Voco GmbH | EBF Resin Tooth Shade Material |
| 27 Apr 2026 | K261356 | Dura-Crown | Hangzhou SHINING3D Dental Technology Co., Ltd | EBF Resin Tooth Shade Material |
| 23 Apr 2026 | K260152 | Smart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3-HT, BL1-HT, B1-HT) | Mmtech Projetos Tecnologicos Importacao E Exportacao Ltda. | EBF Resin Tooth Shade Material |
| 17 Apr 2026 | K261261 | Dura-Arch | Hangzhou SHINING3D Dental Technology Co., Ltd | EBG Resin Temporary Crown and Bridge |
| 16 Apr 2026 | K253804 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 15 Apr 2026 | K260722 | SureSmile Aligner (ASSY500020) | Dentsply Sirona, Inc. | NXC Sequential Aligner |
| 15 Apr 2026 | K260661 | Midas Restore | SprintRay Inc. | EBF Resin Tooth Shade Material |
| 15 Apr 2026 | K253337 | REGEN Bioactive Cement | Inter-Med, Inc. | EMA Dental Cement |
| 10 Apr 2026 | K260430 | Porcelain Etch Gel | Belport Company, Inc., Gingi-Pak | KLE Resin Tooth Bonding Agent |
| 10 Apr 2026 | K260082 | TRIOS Dx (R1) | 3Shape Trios | SHQ In-Office Dental Image Analyzer |
| 10 Apr 2026 | K252942 | ShaeferH | Shaeferh, LLC | LRK Anti-Snoring Device |
| 9 Apr 2026 | K260555 | LOCATOR® Angled Abutment | Zest Anchors, LLC | NHA Endosseous Dental Implant Abutment |
| 9 Apr 2026 | K260462 | RCT800 | Ray Co., Ltd, | OAS Dental Computed Tomography X-Ray |
| 9 Apr 2026 | K260067 | Eternal Art Porcelain Powders | Shandong Huge Dental Material Corporation | EIH Porcelain Powder |
| 6 Apr 2026 | K254091 | GLOSSY COAT (15ML) | Yamahachi Dental Mfg. Co. | EBD Resin Filling Material Coating |
| 6 Apr 2026 | K253036 | Light-curing Coloring Materials (ALCM) | Aidite (Qinhuangdao) Technology Co., Ltd | EBF Resin Tooth Shade Material |
| 6 Apr 2026 | K252765 | ProSomnus RPMO2 OSA Device (RPMO2 OSA) | ProSomnus Sleep Technologies | PLC Sleep Appliances with Patient Monitoring |
| 2 Apr 2026 | K252246 | Leforte MMF System | Jeil Medical Corporation | JEY Bone Plate |
| 31 Mar 2026 | K260093 | Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS) | VATECH Co., Ltd. | OAS Dental Computed Tomography X-Ray |
| 30 Mar 2026 | K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Bloomden Bioceramics (HuNan) Co.,Ltd. | EIH Porcelain Powder |
| 23 Mar 2026 | K252031 | Adin Long Dental Implant System | ADIN DENTAL IMPLANT SYSTEMS Ltd | DZE Root-Form Endosseous Implant |
| 20 Mar 2026 | K253864 | NOMAD Pro 3 | Dental Imaging Technologies Corporation | EHD Extraoral with Timer X-Ray Unit |
| 20 Mar 2026 | K252606 | Bifix Veneer LC, Bifix Veneer Try-In | Voco GmbH | EMA Dental Cement |
| 19 Mar 2026 | K254112 | Dia-X Sil Bite | DiaDent Group International | ELW Impression Material |
| 18 Mar 2026 | K260830 | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) | Sangi Co., Ltd. | LBH Cavity Varnish |
| 17 Mar 2026 | K251926 | enCore Impression Material | Encore Guards | SHI Over-the-Counter Impression Material for Fabrication of Patient-Matched Mouthguards |
| 16 Mar 2026 | K253334 | ZENEX Implant System_Short (R-System) | Izenimplant Co., Ltd. | DZE Root-Form Endosseous Implant |
| 12 Mar 2026 | K252110 | Dental X-RAY Unit (AJX200) | Guangzhou Ajax Medical Equipment Co., Ltd. | EHD Extraoral with Timer X-Ray Unit |
| 11 Mar 2026 | K260783 | Venus Diamond; Venus Diamond Flow; Venus Pearl; Venus Bulk Flow One | Kulzer, LLC | EBF Resin Tooth Shade Material |
| 10 Mar 2026 | K260773 | Varios Combi Pro2 | Nakanishi, Inc. | ELC Ultrasonic Scaler |
| 10 Mar 2026 | K253953 | IPS e.max Zirconia | Ivoclar Vivadent, AG | EIH Porcelain Powder |
| 10 Mar 2026 | K252353 | myray ProXIma X6 | Cefla S.C. | OAS Dental Computed Tomography X-Ray |
| 10 Mar 2026 | K252168 | Straumann® BLC Implants - Indication Widening | Institut Straumann AG | DZE Root-Form Endosseous Implant |
| 6 Mar 2026 | K251818 | BONTREE PLUS | Hudens Bio Co., Ltd. | LYC Synthetic Bone Grafting Material |
| 5 Mar 2026 | K252450 | Adhese 2 | Ivoclar Vivadent, AG | KLE Resin Tooth Bonding Agent |
| 4 Mar 2026 | K253565 | SureSmile Software | Dentsply Sirona, Inc. | PNN Orthodontic Software |
| 4 Mar 2026 | K253493 | Dentis SQ-SL AXEL Fixture | Dentis Co., Ltd. | DZE Root-Form Endosseous Implant |
| 4 Mar 2026 | K251434 | Healing Abutment System | Osstem Implant Co., Ltd. | NHA Endosseous Dental Implant Abutment |
| 3 Mar 2026 | K260682 | Bond-PR Universal Adhesive | Premier Dental Products Company | KLE Resin Tooth Bonding Agent |
| 3 Mar 2026 | K254245 | ZAFIRA® | New Stetic, SA | EBF Resin Tooth Shade Material |
| 3 Mar 2026 | K253845 | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) | Ram.Shaw Pte., Ltd. | LRK Anti-Snoring Device |
| 3 Mar 2026 | K251793 | SOTA Cloud Smart Sensor (1.5) | SOTA Cloud Corporation | MUH Digital Extraoral Source X-Ray System |
| 2 Mar 2026 | K253380 | FLNT Base and FLNT Temp | Liaoning Upcera Co., Ltd | EBG Resin Temporary Crown and Bridge |
| 2 Mar 2026 | K252531 | Myosa (S1H, S1, S2, S3, S1M, S2M); Myosa for Snorers (S1, S1M, S2) | Myofunctional Research Co. Usa Inc. | LRK Anti-Snoring Device |
| 25 Feb 2026 | K251724 | Remi Impression Material | GrindGuard Inc | SHI Over-the-Counter Impression Material for Fabrication of Patient-Matched Mouthguards |
| 23 Feb 2026 | K251587 | VITA VMLC Primer | Vita Zahnfabrik H. Rauter GmbH & Co. Kg. | KLE Resin Tooth Bonding Agent |
| 19 Feb 2026 | K254018 | Portable Dental X-ray Device (GT-1) | Guilin Refine Medical Instrument Co., LTD. | EHD Extraoral with Timer X-Ray Unit |
| 18 Feb 2026 | K252197 | Nobel Biocare S Series Implants | Nobel Biocare Services AG | DZE Root-Form Endosseous Implant |
| 10 Feb 2026 | K251515 | Solidex® Ti-Links and Screws | Creodent Hudson Valley | NHA Endosseous Dental Implant Abutment |
| 5 Feb 2026 | K253959 | Primevision 3D | Dentsply Sirona, Inc. | OAS Dental Computed Tomography X-Ray |
| 3 Feb 2026 | K253282 | ZSmile System | Dror Orthodesign , Ltd. | NXC Sequential Aligner |
| 3 Feb 2026 | K252909 | Diagnostic X-Ray Equipment Model POCT22 | Ningbo Runyes Medical Instrument Co., Ltd. | EHD Extraoral with Timer X-Ray Unit |
| 2 Feb 2026 | K252286 | BIORES Dental Implant System | Chengdu Besmile Medical Technology Co., Ltd. | DZE Root-Form Endosseous Implant |
| 30 Jan 2026 | K254283 | BruxZir® Shaded 16 PLUS | Prismatik Dentalcraft, Inc. | EIH Porcelain Powder |
| 30 Jan 2026 | K251407 | Motor Handpiece and Control Unit (SDI10) | Saeshin Precision Co., Ltd. | EBW Handpiece and Cord Foot Controller |
| 29 Jan 2026 | K251427 | EK MULTI ANGLED 30 ABUTMENT | Hiossen Inc. | NHA Endosseous Dental Implant Abutment |
| 29 Jan 2026 | K243732 | Multi-Unit DAS System | Talladium Espana, SL | NHA Endosseous Dental Implant Abutment |
| 28 Jan 2026 | K253254 | GBT Machine Airflow Prophylaxis Master | E.M.S Electro Medical Systems S.A | ELC Ultrasonic Scaler |
| 22 Jan 2026 | K253315 | Straumann Variobase Abutments XC for Bridge/Bar | Institut Straumann AG | NHA Endosseous Dental Implant Abutment |
| 22 Jan 2026 | K253253 | IPDmilled Blanks | Implant Protesis Dental 2004, S.L. | NHA Endosseous Dental Implant Abutment |
| 21 Jan 2026 | K260170 | LumiCera | Hangzhou SHINING3D Dental Technology Co., Ltd | EBF Resin Tooth Shade Material |
| 13 Jan 2026 | K253248 | Bright Cavity Liner | DMP Dental Industry S.A. | EJK Calcium Hydroxide Cavity Liner |
| 12 Jan 2026 | K253167 | Any-Paste | Mediclus Co., Ltd | KIF Root Canal Filling Resin |
| 12 Jan 2026 | K251701 | Star E900 Electric System | Dentalez, Inc. | EBW Handpiece and Cord Foot Controller |
| 12 Jan 2026 | K251389 | High speed air turbine handpiece | Foshan Topmed Dental Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 12 Jan 2026 | K251388 | Dental 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) | Foshan Topmed Dental Co., Ltd. | EFB Dental Air-Powered Handpiece |
| 9 Jan 2026 | K253973 | Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series | Liaoning Upcera Co., Ltd | EIH Porcelain Powder |
| 8 Jan 2026 | K252585 | ZENEX Implant System_R-System | Izenimplant Co., Ltd. | DZE Root-Form Endosseous Implant |
| 7 Jan 2026 | K252890 | ZenSeal Pro | Sybron Dental Specialties | KIF Root Canal Filling Resin |
| 7 Jan 2026 | K252727 | Neodent InLab Validated Workflow | Institut Straumann AG | NHA Endosseous Dental Implant Abutment |
| 7 Jan 2026 | K252507 | SmileInspector | Amv Consulting, LLC | PNN Orthodontic Software |
| 7 Jan 2026 | K251454 | Clear Aligner (SCF-3348) | Beame Medical Technology (Shenzhen) Limited | NXC Sequential Aligner |
| 29 Dec 2025 | K253343 | Celebrace Software | Celebrace | PNN Orthodontic Software |
| 23 Dec 2025 | K254163 | VarioSurg 4 | Nakanishi, Inc. | DZI Powered Bone Drill |
| 23 Dec 2025 | K253341 | Custom Abutments AS | Institut Straumann AG | NHA Endosseous Dental Implant Abutment |
| 23 Dec 2025 | K253312 | OrangeCAD Med Abutments | OrangeCAD Med GmbH | NHA Endosseous Dental Implant Abutment |
| 23 Dec 2025 | K252145 | GEN5 and GEN5+ 3.3mmD Dental Implants | Paragon Implant Mfg., LLC | DZE Root-Form Endosseous Implant |
| 23 Dec 2025 | K250476 | NizPlant Dental Implant System | Paragon Implant Mfg., LLC | DZE Root-Form Endosseous Implant |
| 22 Dec 2025 | K251605 | DIMPLO Implant System | DIMPLO Ltd. | DZE Root-Form Endosseous Implant |
| 19 Dec 2025 | K254063 | iCEM Universal Plus | Kulzer, LLC | EMA Dental Cement |
| 19 Dec 2025 | K253373 | Southern Craniomaxillofacial (CMF) System | Southern Medical (Pty) Ltd | JEY Bone Plate |
| 18 Dec 2025 | K252976 | Park Dental Nylon MAD | Park Dental Research Corp | LRK Anti-Snoring Device |
| 18 Dec 2025 | K252320 | SIMDA Abutments | Simda Co., Ltd. | NHA Endosseous Dental Implant Abutment |
| 12 Dec 2025 | K252785 | TopCEM Vigor SA Self-Adhesive Resin Cement | Rizhao HuGe Biomaterials Company, Ltd. | EMA Dental Cement |
| 12 Dec 2025 | K252090 | Pterygoid Indication for GM Helix Implants | Institut Straumann AG | DZE Root-Form Endosseous Implant |
| 12 Dec 2025 | K242817 | Jason membrane | botiss biomaterials GmbH | NPL Intraoral Animal Source Barrier |
| 9 Dec 2025 | K252808 | GlasIonomer FX-LC | Shofu Inc | EMA Dental Cement |
| 9 Dec 2025 | K252343 | Atlantis® Abutments in Titanium | Dentsply Sirona, Inc. | NHA Endosseous Dental Implant Abutment |
| 8 Dec 2025 | K252789 | Glass Ceramic | Shenzhen Xiangtong Co., Ltd. | EIH Porcelain Powder |
| 5 Dec 2025 | K253868 | QuietLab Pro | QuietLab | LRK Anti-Snoring Device |
| 5 Dec 2025 | K252465 | Any-Core | Mediclus Co., Ltd | EBF Resin Tooth Shade Material |
| 5 Dec 2025 | K252151 | els unibond | Saremco Dental AG | KLE Resin Tooth Bonding Agent |
| 5 Dec 2025 | K250512 | Augmented Gingival Matrix | Neo Modulus (Suzhou) Medical Sci-Tech Co., Ltd. | NPL Intraoral Animal Source Barrier |
| 27 Nov 2025 | K252760 | Carriere® Motion Pro® Clear Bite Corrector | Ortho Organizers, Inc. | DYW Orthodontic Plastic Bracket |
| 26 Nov 2025 | K252248 | CEREC Tessera Abutment System | Dentsply Sirona, Inc. | NHA Endosseous Dental Implant Abutment |
| 26 Nov 2025 | DEN240077 | MuReva OM | MuReva Phototherapy Inc. | SGQ Intraoral Phototherapy Device |
| 25 Nov 2025 | K253365 | LuxCreo Flexible Partial Denture Resin | LuxCreo Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 25 Nov 2025 | K252253 | Geistlich Mucograft® /Geistlich Mucograft® Seal; Geistlich Fibro-Gide® | Geistlich Pharma AG | NPL Intraoral Animal Source Barrier |
| 25 Nov 2025 | K252161 | Hushd Avera | Good Sleep Co Pte Ltd | LRK Anti-Snoring Device |
| 25 Nov 2025 | K251798 | RCT700 | Ray Co., Ltd, | OAS Dental Computed Tomography X-Ray |
| 21 Nov 2025 | K253681 | TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard Denture (THD-C-1000); TERA HARZ Hard Denture (THD-LP-500); TERA HARZ Hard Denture (THD-LP-1000); TERA HARZ Hard Denture (THD-P-500); TERA HARZ Hard Denture (THD-P-1000); TERA HARZ Hard Denture (THD-CP-500); TERA HARZ Hard Denture (THD-CP-1000) | Graphy, Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 21 Nov 2025 | K251205 | Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants | Dentsply Sirona, Inc. | NHA Endosseous Dental Implant Abutment |
| 21 Nov 2025 | K250714 | FluoroDose Varnish | Centrix, Inc. | LBH Cavity Varnish |
| 20 Nov 2025 | K253324 | UltraPrint-Dental Denture UV | Guangzhou Heygears IMC., Inc. | EBI Rebasing Repairing Relining Denture Resin |
| 18 Nov 2025 | K252582 | Inclusive® Titanium Abutments compatible with: Camlog® CONELOG® Implant System, Dentium® NR Line Implant Systems | Prismatik Dentalcraft, Inc. | NHA Endosseous Dental Implant Abutment |
| 13 Nov 2025 | K251842 | Dental Computed Tomography X-ray System | Fussen Technology Co., Ltd | OAS Dental Computed Tomography X-Ray |
| 10 Nov 2025 | K252570 | EzSensor HD, EzSensor UHD | Qpix Solutions, Inc. | MUH Digital Extraoral Source X-Ray System |
| 7 Nov 2025 | K253513 | MultiMatch Flow Chameleon AntiMicrobial Composite | Premier Dental Products Company | EBF Resin Tooth Shade Material |
| 7 Nov 2025 | K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System | Beijing Naton Technology Group Co. Ltd. | JEY Bone Plate |
| 7 Nov 2025 | K251129 | S.I.N. Tapered Pro Conical Zygoma Implant System | S.i.n. - Sistema de Implante Nacional S.A. | DZE Root-Form Endosseous Implant |
| 7 Nov 2025 | K250739 | Primeprint Direct Aligner | Dreve Dentamid GmbH | NXC Sequential Aligner |
| 6 Nov 2025 | K252525 | AIO Breathe | Aiomega, LLC | LRK Anti-Snoring Device |
| 6 Nov 2025 | K252469 | MAGNABOND SE; MAGNABOND UNIVERSAL; MAGNABOND UNIVERSAL DCA | DMP Dental Industry S.A. | KLE Resin Tooth Bonding Agent |
| 3 Nov 2025 | K252698 | NightGuard Aire Max | Nightguard Express, LLC | LRK Anti-Snoring Device |
| 3 Nov 2025 | K251626 | Midmark Dental Delivery System | Midmark Corporation | EIA Operative Dental Unit |
| 31 Oct 2025 | K253501 | Hydro Print Premium Fast Set - 454g (1lb) (052037); Hydro Print Premium Regular Set - 454g (1lb) (052327); Chroma Print Premium Fast Set - 454g (1lb) (052457); Chroma Print Premium Regular Set - 454g (1lb) (051460); Perfil Pro - 454g (1lb) (056213); Perfil Pro+ - 454g (1lb) (056121); Perfil Pro Chroma - 454g (1lb) (056122); Hydro Print Premium Fast Set - Multi Pack (056205); Hydro Print Premium Regular Set - Multi Pack (056208); Hydro Print Premium Fast Set - 9,07Kg (20lb) (056204); | Vigodent Industria e Comercio Ltda | ELW Impression Material |
| 31 Oct 2025 | K251547 | DESS Dental Smart Solutions | Terrats Medical, S.L. | NHA Endosseous Dental Implant Abutment |
| 30 Oct 2025 | K252430 | Freeprint® denture flex | Detax GmbH | EBI Rebasing Repairing Relining Denture Resin |
| 30 Oct 2025 | K251938 | GEN5 and GEN5+ Dental Implant System | Paragon Implant Mfg., LLC | DZE Root-Form Endosseous Implant |
| 29 Oct 2025 | K253355 | Difiney Advanced Anti Snoring Device 4.0 | Fissiontech LLC | LRK Anti-Snoring Device |
| 28 Oct 2025 | K252376 | Yomi S Robotic System | Neocis | PLV Dental Stereotaxic Instrument |
| 28 Oct 2025 | K252165 | ZIRCONOMER P | Shofu Inc | EMA Dental Cement |
| 24 Oct 2025 | K251784 | Hushd Pro Z-Link | Good Sleep Co Pte Ltd | LRK Anti-Snoring Device |
Showing the 250 most recent. Older clearances are on each company and device page.
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026