Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 33
- Latest Decision
- 2023-11-02
Clearances · page 8 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K233518 | BASE290 LED Curing Light | Handpiece Headquarters | EBZ | Class II | 2023-11-02 |
| K233502 | TERA HARZ II | Graphy, Inc. | EBF | Class II | 2023-11-01 |
| K232099 | Neodent Implant System - GM Zygomatic Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. | DZE | Class II | 2023-10-31 |
| K231874 | AOT & T-L Abutment | Truabutment, Inc. | NHA | Class II | 2023-10-30 |
| K232393 | BluTube® Dental Unit Water Purification Cartridge (BluTube®); Model Numbers: WB180, WB90, Z3 Waterline Purification Straws, Dental Unit Water Purification Cartridge | Proedge Dental Products, Inc. | QYJ | Class I | 2023-10-27 |
| K222459 | Centrix FluoroSilver Silver Diamine Fluoride 38% | Centrix, Inc. | PHR | Class II | 2023-10-27 |
| K232271 | SIMDA abutment | Simda Co., Ltd. | NHA | Class II | 2023-10-26 |
| K221315 | UNIdental Symphony Implant System | Unidental Co., Ltd. | DZE | Class II | 2023-10-25 |
| K232552 | TuxDeluxe (Size 1 6100B, Size 2 6101B) | Tuxedo Imaging, LLC | MUH | Class II | 2023-10-20 |
| K231388 | NextDent Base | Vertex-Dental B.V. | EBI | Class II | 2023-10-20 |
| K230998 | Digital Wireless Intraoral X-Ray Sensor | Iray Imaging Technology (Haining) Limited | MUH | Class II | 2023-10-20 |
| K231578 | Lucitone Digital Print Denture System | Dentsply Sirona | EBI | Class II | 2023-10-20 |
| K230199 | Byte Aligner System | Dentsply Sirona, Inc. | NXC | Class II | 2023-10-18 |
| K231395 | INNO SLA Submerged Narrow Implant System | Cowellmedi Co., Ltd. | DZE | Class II | 2023-10-18 |
| K232151 | Dynamic TiBase | Talladium España, SL | NHA | Class II | 2023-10-17 |
| K230104 | Anthogyr AXIOM® BL X3 implants, Anthogyr Multi-Unit components for AXIOM® BL | Anthogyr | DZE | Class II | 2023-10-16 |
| K223697 | MRI compatibility for existing BioHorizons dental implants and abutments | BioHorizons Implant Systems, Inc. | DZE | Class II | 2023-10-13 |
| K232429 | Titan Dental Design | Clearadvance, LLC | PNN | Class II | 2023-10-13 |
| K231672 | S1 | Medpark Co., Ltd. | NPM | Class II | 2023-10-13 |
| K230618 | MegaGen Dental Implant Systems Portfolio - MR Conditional | Megagen Implant Co., Ltd. | DZE | Class II | 2023-10-11 |
| K230916 | WeSensor | Picopack, Inc. | MUH | Class II | 2023-10-10 |
| K231413 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | NHA | Class II | 2023-10-10 |
| K230091 | THE Cover | Purgo Biologics, Inc. | NPL | Class II | 2023-10-06 |
| K230242 | OsteoCentric Dental Implant System | OsteoCentric Technologies | DZE | Class II | 2023-10-05 |
| K221972 | Warantec Custom Abutment | Warantec Co., Ltd. | NHA | Class II | 2023-10-02 |
| K231520 | tmCMF Solution | Techmah Cmf | DZJ | Class II | 2023-10-02 |
| K233257 | 3M ClarityAligners with Quick Attachments | 3M Company, Unitek Orthodontic Products | NXC | Class II | 2023-09-29 |
| K232299 | CeraPutty | Meta Biomed Co., Ltd. | KIF | Class II | 2023-09-29 |
| K233161 | BeautiLink SA | Shofu Dental Corporation | EMA | Class II | 2023-09-28 |
| K232255 | EZSensor XHD | Qpix Solutions, Inc. | MUH | Class II | 2023-09-27 |
| K232233 | Invisalign System with Mandibular Advancement Featuring Occlusal Blocks | Align Technology, Inc. | NXC | Class II | 2023-09-26 |
| K223496 | Inclusive® Titanium Abutments compatible with: Straumann® Bone Level SC, BioHorizons® Tapered Internal, MIS® C1 Implant Systems | Prismatik Dentalcraft, Inc. | NHA | Class II | 2023-09-26 |
| K230398 | MedCAD® AccuPlate® 3DTi Patient-Specific Plating System | Medcad | JEY | Class II | 2023-09-26 |
| K222778 | Osstem Implant System | Osstem Implant Co., Ltd. | DZE | Class II | 2023-09-23 |
| K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors | Foshan Coxo Medical Instrument Co., Ltd. | EFB | Class I | 2023-09-22 |
| K232978 | DX. Bond V Dental Bonding Adhesive | Sino-Dentex Co., Ltd. | KLE | Class II | 2023-09-22 |
| K231663 | The AVEOtsd (Tongue Stabilizing Device) Mouthpiece | Innovative Health Technologies (Nz), Ltd. | LRK | Class II | 2023-09-18 |
| K231827 | BTI Dental Implant System UnicCa® Aesthetic Post Abutments | B.T.I. Biotechnology Institute, Sl. | NHA | Class II | 2023-09-15 |
| K231235 | LW UCLA Abutment | Ossvis Co., Ltd. | NHA | Class II | 2023-09-15 |
| K230108 | Straumann® BLC and TLC Implants | Institut Straumann AG | DZE | Class II | 2023-09-14 |
| K232827 | LightForce Orthodontic System | Lightforce Orthodontics | NJM | Class II | 2023-09-14 |
| K231079 | LW Retraction Cap | Ossvis Co., Ltd. | NHA | Class II | 2023-09-14 |
| K232158 | GenX-CR | Genoray Co., Ltd. | MUH | Class II | 2023-09-13 |
| K231687 | Gradual Dental Zirconia Blank | Liaoning Upcera Co., Ltd. | EIH | Class II | 2023-09-07 |
| K230644 | Signum opaque F | Kulzer, LLC | EBF | Class II | 2023-09-07 |
| K232691 | Polibond | Zirkonzahn Srl | EBI | Class II | 2023-09-05 |
| K232068 | HyperLight Portable X-ray Unit | Changzhou Sifary Medical Technology Co., Ltd. | EHD | Class II | 2023-09-01 |
| K230317 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | NHA | Class II | 2023-09-01 |
| K231884 | TRIOCLEAR System | Modern Dental Laboratory (Dg) Co., Ltd. | NXC | Class II | 2023-09-01 |
| K223901 | ApneaRX Pro | Apnea Sciences Coporation | LRK | Class II | 2023-09-01 |
| K232657 | InnerView LC | Perimetrics, Inc. | EKX | Class I | 2023-09-01 |
| K231599 | Stryker MP, Mandible, HMMF and MMF AXS Screws | Stryker Leibinger GmbH & Co KG | DZL | Class II | 2023-08-24 |
| K231557 | ZENEX FreeMilling & CCM Cast Abutment | Izenimplant Co., Ltd. | NHA | Class II | 2023-08-24 |
| K232243 | EVO 700 series high speed handpiece | Ttbio Corp. | EFB | Class I | 2023-08-23 |
| K222946 | Oneday Mini Implant System | Oneday Biotech Co., Ltd. | DZE | Class II | 2023-08-23 |
| K222245 | ACR Screw System | Biomaterials Korea, Inc. | OAT | Class II | 2023-08-21 |
| K220253 | Eco Abutment, Multiunit Abutment | Dio Corporation | NHA | Class II | 2023-08-18 |
| K232498 | UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by Nobio | Ultradent Product, Inc. | EBC | Class II | 2023-08-18 |
| K223912 | InterCollagen® Guide | Sigmagraft, Inc. | NPL | Class II | 2023-08-17 |
| K231389 | Harvest Dental HD Gum Strip | Harvest Dental Products, LLC | EBI | Class II | 2023-08-16 |
| K231087 | Guided Surgery Kit | Implant Direct Sybron Manufacturing, LLC | DZI | Class II | 2023-08-16 |
| K231455 | Implant-One System | Implant Logistics, Inc. | NHA | Class II | 2023-08-15 |
| K231434 | DESS Dental Smart Solutions | Terrats Medical SL | NHA | Class II | 2023-08-14 |
| K231018 | Yomi Robotic System | Neocis, Inc. | PLV | Class II | 2023-08-14 |
| K231696 | Fusion Bond 5, Fusion Bond 7, Fusion Bond DC, Renew MDP, Renew Universal | Prevest Denpro Limited | KLE | Class II | 2023-08-11 |
| K223924 | LW Implant System | Ossvis Co., Ltd. | DZE | Class II | 2023-08-08 |
| K230733 | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG | JEY | Class II | 2023-08-05 |
| K223507 | CL-DP40 (Drs Light PRIME), CL-DP40 (Drs Light CHOICE) | Good Doctors Co., Ltd. | EBZ | Class II | 2023-08-04 |
| K230126 | Dentis s-Clean Regular Abutment | Dentis Co., Ltd. | NHA | Class II | 2023-08-04 |
| K230873 | Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments | Southern Implants (Pty), Ltd. | NHA | Class II | 2023-08-01 |
| K231591 | V-Print c&b temp | Voco GmbH | POW | Class II | 2023-07-31 |
| K230630 | ZENEX Implant System_Narrow | Izenimplant Co., Ltd. | DZE | Class II | 2023-07-31 |
| K231552 | Dia-Cem | DiaDent Group International | EMA | Class II | 2023-07-28 |
| K231480 | Bright MTA Sealer Plus | Genoss Co., Ltd. | KIF | Class II | 2023-07-28 |
| K230455 | Enamel Coating Resin | Rizhao Huge Biomaterials Company, Ltd. | EBC | Class II | 2023-07-25 |
| K230333 | Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800) | Kettenbach GmbH & Co. KG | LBH | Class II | 2023-07-24 |
| K231523 | EsCom250 | Spident Co., Ltd. | EBF | Class II | 2023-07-24 |
| K223339 | Bone Chamber Implant | Megagen Implant Co., Ltd. | DZE | Class II | 2023-07-18 |
| K221107 | TRUST | Rgorithm Korea | PNP | Class II | 2023-07-18 |
| K230445 | OnX Tough | Sprintray, Inc. | EBI | Class II | 2023-07-14 |
| K221673 | Bonafix TiBase | Zentek Medical, LLC | NHA | Class II | 2023-07-14 |
| K223173 | Proxeo ULTRA (PB-510, PB-520 and PB-530) | W&H Dentalwerk Buermoss GmbH | ELC | Class II | 2023-07-14 |
| K222026 | Neodent Implant System - Zirconia Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | NHA | Class II | 2023-07-14 |
| K231449 | Portable X-ray System Model Ray98(P) | Ningbo Runyes Medical Instrument Co., Ltd. | EHD | Class II | 2023-07-13 |
| K230877 | Admira Fusion 5 | Voco GmbH | EBF | Class II | 2023-07-13 |
| K230532 | RADx Intraoral Appliance for Snoring and Sleep Apnea | Achaemenid, LLC | LQZ | Class II | 2023-07-12 |
| K230307 | Dentis i-Clean System | Dentis Co., Ltd. | NHA | Class II | 2023-07-11 |
| K231387 | Endofill | Lumendo AG | KIF | Class II | 2023-07-10 |
| K232011 | Cleo | American Orthodontics | NJM | Class II | 2023-07-07 |
| K222707 | IH Implant System | Sewonmedix, Inc. | DZE | Class II | 2023-07-07 |
| K223780 | Lumos 3DX | 3Dio | EHD | Class II | 2023-07-06 |
| K230487 | Dental Lithium Disilicate Glass-Ceramic | Fuzhou Rick Brown Biomaterials Co., Ltd. | EIH | Class II | 2023-07-03 |
| K230725 | NB Implant System | Arum Dentistry Co., Ltd. | DZE | Class II | 2023-07-01 |
| K231264 | Easy On Universal Glaze & Stain | Doctus Global | EIH | Class II | 2023-06-30 |
| K221488 | Z7 Zirconia Implant System | Z7, LLC | DZE | Class II | 2023-06-26 |
| K222142 | BR SLA Type Implant System | Biotem Co., Ltd. | DZE | Class II | 2023-06-24 |
| K230276 | TECHFIT DISRP® System | Techfit Digital Surgery | DZJ | Class II | 2023-06-23 |
| K223638 | Neodent Implant System - Helix Short Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | DZE | Class II | 2023-06-23 |
| K230410 | DD medical polymers (PMMA) | Dental Direkt GmbH | EBI | Class II | 2023-06-23 |
| K222323 | Black Diamond | Elevate Oral Care, LLC | PHR | Class II | 2023-06-23 |
12,679 clearances in the Dental panel. Data: openFDA.