Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 36
- Latest Decision
- 2026-10-01
Clearances · page 1 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K260027 | Firstar Dental Electric Motor | FDC Technology Industry Co. | EBW | Class I | 2026-10-01 |
| K260029 | Firstar Dental Handpieces | FDC Technology Industry Co. | EFB | Class I | 2026-10-01 |
| K261327 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | NHA | Class II | 2026-09-30 |
| K261663 | EzSensor HD | Qpix Solutions, Inc. | MUH | Class II | 2026-09-30 |
| K262983 | EsTemp Implant | Spident Co., Ltd. | EMA | Class II | 2026-09-25 |
| K262196 | Invisalign System | Align Technology, Inc. | PNN | Class II | 2026-09-25 |
| K254210 | REBOHIL (BGM-1, BGM-2, BGM-3, BGM-4, BGM-5) | Hyundai Bioland Co., Ltd. | NPM | Class II | 2026-09-25 |
| K262252 | MPa Max adhesive | Den-Mat Holdings, LLC | KLE | Class II | 2026-09-24 |
| K262207 | Cemented Plus Abutment | Unidental Co., Ltd. | NHA | Class II | 2026-09-23 |
| K262144 | DIAMED Handpiece;DIAMED Airmotor;DIAMED Airmotor Handpiece | SETAGAYA SEIKI Co., Ltd. | EFB | Class I | 2026-09-23 |
| K262982 | Core·it Dual | Spident Co., Ltd. | EBF | Class II | 2026-09-21 |
| K260940 | BellaTek Bars | ZimVie US Corp, LLC | NHA | Class II | 2026-09-21 |
| K261392 | TriActive Dental Implant System | Paragon Implant Mfg., LLC | DZE | Class II | 2026-09-17 |
| K261888 | ClearClub Impression Material | ClearClub | SHI | Class II | 2026-09-16 |
| K254152 | Dia-X Sil Light Body | DiaDent Group International | ELW | Class II | 2026-09-16 |
| K254142 | Dia-X Sil Heavy Body | DiaDent Group International | ELW | Class II | 2026-09-16 |
| K260795 | Hand-held Dental X-ray System (HyperLight-M) | Changzhou Sifary Medical Technology Co., Ltd. | EHD | Class II | 2026-09-14 |
| K262050 | Vioseal X | Spident Co., Ltd. | KIF | Class II | 2026-09-11 |
| K262202 | Cerasmart Forte | GC America, Inc. | EBF | Class II | 2026-09-10 |
| K254009 | Portable Dental Unit (PC 2630, OMC 2375CV, MC 3600CV) | Lakong Medical Devices Co., Ltd. | SJH | Class I | 2026-09-10 |
| K261987 | Reusable SmartPeg | Osstell AB | EKX | Class I | 2026-09-08 |
| K253909 | NeoPEX Pre-Mixed Obturation Paste | NuSmile, Ltd. | KIF | Class II | 2026-09-04 |
| K262243 | Profisil Free | Kettenbach GmbH & Co. KG | LBH | Class II | 2026-09-03 |
| K261695 | Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF) | Guilin Kevin Peter Technology Co., Ltd. | EBF | Class II | 2026-08-31 |
| K253954 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | QRY | Class II | 2026-08-28 |
| K262104 | Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT) | Ram.Shaw Pte., Ltd. | LRK | Class II | 2026-08-27 |
| K261802 | Glidewell Denture Base Resin | Prismatik Dentalcraft, Inc. | EBI | Class II | 2026-08-27 |
| K261514 | Calcium Hydroxide Temporary Filling Material (KP-Cal) | Guilin Kevin Peter Technology Co., Ltd. | KIF | Class II | 2026-08-25 |
| K254304 | iNOS intraoral biosensor | Achaemenid, LLC | PLC | Class II | 2026-08-25 |
| K254286 | Guided Bone Regeneration System | DentalMaster(Xiamen)Medical Technology Co., Ltd. | DZL | Class II | 2026-08-24 |
| K262074 | Any-Zircos | Mediclus Co., Ltd. | EIH | Class II | 2026-08-21 |
| K260463 | ZEROS Dental Implant System | Zeros Co., Ltd. | DZE | Class II | 2026-08-19 |
| 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 L.P. | JEY | Class II | 2026-08-17 |
| K261626 | UltraPrint Flexible Denture UV | Guangzhou Heygears IMC., Inc. | EBI | Class II | 2026-08-13 |
| K254201 | Any-Cem | Mediclus Co., Ltd. | EMA | Class II | 2026-08-13 |
| K261937 | PacTemp Automix NE | The Belport Company Inc., DBA Gingi-Pak | EMA | Class II | 2026-08-07 |
| K251544 | Dental Unit (MP2000-550LED-2.0, LP2100-550LED-2.0) | Lakong Medical Devices Co., Ltd. | EIA | Class I | 2026-08-07 |
| 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 AB | NHA | Class II | 2026-08-06 |
| K261456 | Ruthinium Disc | Dental Manufacturing S.p.A. | POW | Class II | 2026-08-05 |
| K262681 | NanoCeram Resin | 3BFAB TEKNOLOJI A.S. | EBI | Class II | 2026-07-31 |
| K261912 | SnØreNegatØr | DnB Innovations, LLC | LRK | Class II | 2026-07-31 |
| K253655 | Angled Screwdriver MED (M-SD090) | W&H Dentalwerk Bürmoos GmbH | DZI | Class II | 2026-07-31 |
| K262239 | Obsidian® Press Over Zirconia | Prismatik Dentalcraft, Inc. | EIH | Class II | 2026-07-30 |
| K253206 | METICULY Patient-specific CMF solution | Meticuly Co., Ltd. | JEY | Class II | 2026-07-25 |
| K261728 | One-Fil LC | Mediclus Co., Ltd. | EJK | Class II | 2026-07-21 |
| K261046 | Dental Zirconia Blank & Coloring Liquid | Hunan Qinghao Puzhong Technology Co., Ltd. | EIH | Class II | 2026-07-17 |
| K261166 | DIA-CEM | DiaDent Group International | EMA | Class II | 2026-07-09 |
| K262300 | Denture Base Resin V2 | Formlabs Ohio, Inc. | EBI | Class II | 2026-07-08 |
| K253317 | Cytrans Elashield | GC America, Inc. | LYC | Class II | 2026-07-06 |
| K261847 | iTero Lumina Pro | Align Technology , Ltd. | NTK | Class II | 2026-07-02 |
| K260527 | FACE4D Aligner | Avinent Implant System S.L.U. | NXC | Class II | 2026-07-02 |
| K261129 | OrthoFit | Spident Co., Ltd. | DYH | Class II | 2026-07-02 |
| K262228 | Transcend Bulk Fill Flowable Composite | Ultradent Products, Inc. | EBF | Class II | 2026-07-01 |
| K261485 | Tetric plus Fill;Tetric plus Flow | Ivoclar Vivadent, Inc. | EBF | Class II | 2026-07-01 |
| K261474 | DENTCA Tru Flexible | Dentca, Inc. | EBI | Class II | 2026-07-01 |
| K261147 | Neodent Implant System - NeoConvert Fit | JJGC Indústria e Comércio de Materiais Dentários S.A. | NHA | Class II | 2026-07-01 |
| K262195 | Dandy Ceramic Stain and Glaze | Zima International Inc., dba Dandy | EIH | Class II | 2026-06-30 |
| K261415 | Injectable Root Canal Sealer (KP-Root SP) | Guilin Kevin Peter Technology Co., Ltd. | KIF | Class II | 2026-06-29 |
| K260918 | Zolid Lunaris | Amann Girrbach AG | EIH | Class II | 2026-06-29 |
| K261122 | MIST IC | Imagine Milling Technologies, LLC | NHA | Class II | 2026-06-27 |
| K260061 | BioHorizons CEREC Compatible Ti-Bases | BioHorizons Implant Systems, Inc. | NHA | Class II | 2026-06-26 |
| K251188 | UNIQA® Dental Implants System | Uniqa Dental, Ltd. | DZE | Class II | 2026-06-25 |
| K261246 | SRGC-06 | GC America, Inc. | EBF | Class II | 2026-06-18 |
| K251232 | MegaGen Zygoma Dental Implant System | Megagen Implant Co., Ltd. | DZE | Class II | 2026-06-18 |
| K253776 | Implantmed Plus II & Piezomed Plus II Module | W&H Dentalwerk Buermoos GmbH | DZI | Class II | 2026-06-18 |
| K253131 | Curing Light (M-Cure 6) | Guangzhou Rebornendo Medical Instrument Co., Ltd. | EBZ | Class II | 2026-06-18 |
| K250806 | Dental Implant System | A.B. Dental Devices , Ltd. | DZE | Class II | 2026-06-18 |
| K260006 | INOSS System | Inosys, Inc. | DZE | Class II | 2026-06-17 |
| K253723 | BOSS | Medpark Co., Ltd. | NPM | Class II | 2026-06-16 |
| K253922 | Neodent Scannable Healing Abutment | JJGC Indústria e Comércio de Materiais Dentários S.A. | NHA | Class II | 2026-06-15 |
| K261366 | Virtus | Somnomed, Inc. | LRK | Class II | 2026-06-12 |
| K261251 | Snorbliss® Anti-Snoring Device | Endeavor Commerce, LLC | LRK | Class II | 2026-06-11 |
| K253052 | Fluoride Varnish (Type A,Type C) | Nagy Oral Technology Qinhuangdao Co., Ltd. | LBH | Class II | 2026-06-11 |
| K260859 | Rosetta SM, Rosetta SP | Hass Corp. | EIH | Class II | 2026-06-11 |
| K254145 | Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut) | Smart Denture Conversions, LLC | NHA | Class II | 2026-06-11 |
| K260564 | DESS Dental Smart Solutions | Terrats Medical SL | NHA | Class II | 2026-06-09 |
| K252904 | SIC Abutments including CAD/CAM Solutions | Sic Invent AG | NHA | Class II | 2026-06-03 |
| K261840 | BracePaste Prime Plus | American Orthodontics | DYH | Class II | 2026-06-03 |
| K261826 | VSP System (Titanium Palatal Splint) | 3D Systems, Inc. | DZJ | Class II | 2026-06-03 |
| K260569 | DB 4000 High Impact Denture Base | Carbon, Inc. | EBI | Class II | 2026-06-02 |
| K261093 | DIAFIL | DiaDent Group International | EBF | Class II | 2026-06-02 |
| K260367 | Portable Dental X-ray System Model PDX nova | PDX Co., Ltd. | EHD | Class II | 2026-05-27 |
| K253191 | DCMhotbond zircon | Dental Creativ Management GmbH | EIH | Class II | 2026-05-21 |
| K253774 | Elos Accurate® Denture Fixation System | Elos Medtech Pinol A/S | NHA | Class II | 2026-05-20 |
| K260268 | OrthoEasy Pal; OrthoEasy Pal Long Neck | Bernhard Förster GmbH (Bernhard Foerster Ltd.) | OAT | Class II | 2026-05-19 |
| K261071 | DIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW (Refill Package);DIAFIL Bulk FLOW (0.5g) | DiaDent Group International | EBF | Class II | 2026-05-19 |
| K254109 | G-CEM UNIVERSAL | GC America, Inc. | EMA | Class II | 2026-05-18 |
| K261134 | Dormiva Anti-Snoring Mouth Guard | Koncept Innovators, Inc. | LRK | Class II | 2026-05-14 |
| K253883 | Bonalive Maxillofacial | Bonalive , Ltd. | LYC | Class II | 2026-05-14 |
| K260485 | Any-Etch | Mediclus Co., Ltd. | KLE | Class II | 2026-05-14 |
| K253372 | ET Healing Abutments; ET Scan Healing Abutments; EK Scan Healing Abutments | Hiossen, Inc. | NHA | Class II | 2026-05-14 |
| K252731 | Promimic ZrP Surface Dental Implant; Promimic ZrP + HAnano Surface Dental Implant | Promimic AB | DZE | Class II | 2026-05-12 |
| K260805 | Dual Core | Vericom Co., Ltd. | EBF | Class II | 2026-05-11 |
| K260788 | Smylio Aligners | Smylio, Inc. | NXC | Class II | 2026-05-08 |
| K260419 | LingOral Dental Design System | Hangzhou ChohoTech Co., Ltd. | PNN | Class II | 2026-05-08 |
| K260460 | Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold Hue | Institut Straumann AG | NHA | Class II | 2026-05-07 |
| K260376 | Denture Base | Shandong Huge Dental Material Corporation | EBI | Class II | 2026-05-06 |
| K252073 | VOCO Profluorid Varnish + BioMin | Voco GmbH | LBH | Class II | 2026-05-01 |
| K260819 | Any-Com Seal | Mediclus Co., Ltd. | EBC | Class II | 2026-05-01 |
| K261404 | UltraEZ | Ultradent Products, Inc. | LBH | Class II | 2026-04-30 |
12,679 clearances in the Dental panel. Data: openFDA.