Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 32
- Latest Decision
- 2024-04-04
Clearances · page 7 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K240038 | Clear Moves Aligners | Space Maintainers Laboratories (Sml) | NXC | Class II | 2024-04-04 |
| K232653 | Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX | Blue Sky Bio, LLC | NXC | Class II | 2024-04-03 |
| K240888 | Calibra Abutment Resin Cement | Dentsply Sirona | EMA | Class II | 2024-04-02 |
| K230895 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4, | Cefla S.C. | EBW | Class I | 2024-04-01 |
| K232726 | External Hex Implant System | Southern Implants (Pty), Ltd. | DZE | Class II | 2024-04-01 |
| K232049 | IS-III active Short Implant | Neobiotech Co., Ltd. | DZE | Class II | 2024-03-28 |
| K231132 | J & P Click Attachments | J & P Dental Technologies | NHA | Class II | 2024-03-26 |
| K232268 | STERI-OSS Implant System | Zeros Co., Ltd. | DZE | Class II | 2024-03-25 |
| K233167 | LW Implant System Abutment | Ossvis Co., Ltd. | NHA | Class II | 2024-03-25 |
| K240754 | N2 | Megagen Implant Co., Ltd. | EIA | Class I | 2024-03-21 |
| K240743 | Peak Universal Bond | Ultradent Products, Inc. | KLE | Class II | 2024-03-20 |
| K234049 | Straumann® BLC and TLC Implants - Line extension | Institut Straumann AG | DZE | Class II | 2024-03-20 |
| K240574 | BruxZir® Radiant | Prismatik Dentalcraft, Inc. | EIH | Class II | 2024-03-20 |
| K232682 | Pre-Sintered Zirconia Coloring Liquid | Chengdu Besmile Medical Technology Co., Ltd. | EIH | Class II | 2024-03-19 |
| K240112 | Light Cure Composite | Sincera Technology (Changchun) Co., Ltd. | EBF | Class II | 2024-03-15 |
| K240694 | FORMA Composite (Shade A3D) | Ultradent Products, Inc. | EBF | Class II | 2024-03-15 |
| K231529 | CloudPoint FastDesign Chairside | Prismatik Dentalcraft, Inc. | PNP | Class II | 2024-03-14 |
| K232564 | Align Studio | Laon Medi, Inc. | PNN | Class II | 2024-03-12 |
| K233922 | SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG | Satelec - Acteon Group | ELC | Class II | 2024-03-11 |
| K231864 | Fiber Optic Brushless Electronic Micromotor, model: iM100 | Codent Technical Industry Co., Ltd. | EBW | Class I | 2024-03-11 |
| K233083 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Aka Osteon Medical) | NHA | Class II | 2024-03-09 |
| K240619 | e-SDF | Kids-E-Dental Llp | PHR | Class II | 2024-03-06 |
| K233859 | BASIS FLOW II | YAMAHACHI DENTAL MFG., Co. | EBI | Class II | 2024-03-05 |
| K240597 | TERA HARZ CLEAR | Graphy, Inc. | NXC | Class II | 2024-03-05 |
| K231210 | DGA Abutment | Modern Dental Laboratory (Dg) Co., Ltd. | NHA | Class II | 2024-03-05 |
| K231915 | Zfx Abutments | Zfx GmbH - A Company of Zimvie | NHA | Class II | 2024-03-01 |
| K231845 | Dental unit Model: Mare | Foshan Safety Medical Equipment Co., Ltd. | EIA | Class I | 2024-02-28 |
| K234014 | Obsidian® NOW | Prismatik Dentalcraft, Inc. | EIH | Class II | 2024-02-27 |
| K233995 | Ivotion Base Print | Ivoclar Vivadent, Inc. | EBI | Class II | 2024-02-23 |
| K232174 | rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono | Genoss Co., Ltd. | EIH | Class II | 2024-02-23 |
| K233754 | AIO Breathe | Aiomega, LLC | LQZ | Class II | 2024-02-23 |
| K232074 | Serafin® | Tns Co., Ltd. | NXC | Class II | 2024-02-22 |
| K233544 | MESHEET | Dentis Co., Ltd. | NXC | Class II | 2024-02-22 |
| K231753 | Oneday Implant Abutment | Oneday Biotech Co., Ltd. | NHA | Class II | 2024-02-21 |
| K232148 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | QRY | Class II | 2024-02-21 |
| K233194 | TS Abutment System | Osstem Implant Co., Ltd. | NHA | Class II | 2024-02-20 |
| K231513 | Oral Matrix | Beijing Biosis Healing Biolog Ical Technology Co., Ltd. | NPL | Class II | 2024-02-16 |
| K240427 | airVata | Gelb Practice Solutions, Inc. | LRK | Class II | 2024-02-14 |
| K233954 | Chemi-SiL (HB, MB, LB, LBS); Chemi-SiL Bite-Blu | B&E Korea Co., Ltd. | ELW | Class II | 2024-02-13 |
| K231913 | T-FIT | Techwin Co., Ltd. | OAT | Class II | 2024-02-08 |
| K233914 | XVbeam2000 | Shenzhen Xpectvision Technology Co., Ltd. | EHD | Class II | 2024-02-08 |
| K232182 | One-Fil | Mediclus Co., Ltd. | KIF | Class II | 2024-01-26 |
| K233208 | NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium | Nobel Biocare AB | NHA | Class II | 2024-01-24 |
| K232676 | Dental Porcelain Powder | Chengdu Besmile Medical Technology Co., Ltd. | EIH | Class II | 2024-01-23 |
| K232673 | Dental Glass Ceramics | Chengdu Besmile Medical Technology Co., Ltd. | EIH | Class II | 2024-01-23 |
| K231305 | Endoform Dental Membrane | Aroa Biosurgery , Ltd. | NPL | Class II | 2024-01-23 |
| K232917 | Chemo Mouthpiece | Chemo Mouthpiece, LLC | QUA | Class II | 2024-01-23 |
| K233450 | MegaGen Dental Implant Abutment - Scan Healing Abutment; Temporary Abutment; Temporary Cylinder; Comfort Cap; Healing Cap; Healing Cap Screw; Milling Abutment; EZ Post Abutment; Extra EZ Post Abutment; EZ Post Cylinder; ZrGEN Abutment; Multi-unit Abutment; Multi-unit Angled Abutment; AXA Abutment (Straight); AXA Abutment (Angled); Abutment Screw; Cylinder Screw; Crown Screw | Megagen Implant Co., Ltd. | NHA | Class II | 2024-01-22 |
| K221866 | S-Plant Dental Implant System | Newton Implant Systems, Inc. | DZE | Class II | 2024-01-18 |
| K231138 | Aniti-Snore Mouthguard+ | Oscimed SA | LRK | Class II | 2024-01-16 |
| K232350 | Stryker Facial iD System | Stryker Craniomaxillofacial | JEY | Class II | 2024-01-13 |
| K233125 | Zirconia Block | Hangzhou Ivista Medical Devices Co., Ltd. | EIH | Class II | 2024-01-12 |
| K232170 | Ti Link Abutment | Izenimplant Co., Ltd. | NHA | Class II | 2024-01-12 |
| K233616 | Clevaligner Software (V1.0.0) | Clevaligner, Ltd. | PNN | Class II | 2024-01-11 |
| K231263 | Fusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusion 1 Seal; Magna NT | Prevest Denpro Limited | EBF | Class II | 2024-01-05 |
| K233316 | DESS Dental Smart Solutions | Terrats Medical SL | NHA | Class II | 2024-01-05 |
| K231072 | Anthogyr FlexiBase® titanium bases for Axiom® BL | Anthogyr | NHA | Class II | 2024-01-04 |
| K233395 | Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S) | Alliage S/A Industrias Médico Odontológica | EHD | Class II | 2024-01-03 |
| K230438 | URIS Smart Path Implant System & Prosthetic | Truabutment, Inc. | DZE | Class II | 2023-12-29 |
| K223714 | UniFit Dental Implant System | Adin Dental Implant Systems , Ltd. | DZE | Class II | 2023-12-29 |
| K231055 | x-mind dc (under trademark Acteon), Owandy-RX DC (under trademark OwandyRadiology) | De Götzen S.R.L. | EHD | Class II | 2023-12-28 |
| K234043 | 3M Transbond Orthodontic Adhesive | 3M Unitek Orthodontic Products | DYH | Class II | 2023-12-22 |
| K233082 | TopCEM Dual Cure Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | EBF | Class II | 2023-12-22 |
| K231307 | Elos Accurate Customized Abutment | Elos Medtech Pinol A/S | NHA | Class II | 2023-12-21 |
| K233016 | Dental Glass Ceramics | Shenzhen Yurucheng Dental Materials Co., Ltd. | EIH | Class II | 2023-12-21 |
| K231660 | Digital image scanner of dental | Jiangsu Dynamic Medical Technology Co., Ltd. | MUH | Class II | 2023-12-20 |
| K231411 | INNO SLA Submerged Hybrid Ti-Base System | Cowellmedi Co., Ltd. | NHA | Class II | 2023-12-20 |
| K233163 | ZENEX Implant System_Short | Izenimplant Co., Ltd. | DZE | Class II | 2023-12-19 |
| K232560 | Angled Abutment | Arum Dentistry Co., Ltd. | NHA | Class II | 2023-12-19 |
| K231429 | S-Plant Dental Implant System | Idis Co., Ltd. | DZE | Class II | 2023-12-18 |
| K232887 | Invisalign Palatal Expander System | Align Technology, Inc. | NXC | Class II | 2023-12-15 |
| K223470 | C50 | Sopro | NBL | Class II | 2023-12-14 |
| K231039 | CLEARFIL Universal Bond Quick 2 | Kuraray Noritake Dental, Inc. | KLE | Class II | 2023-12-13 |
| K232063 | SaliPen | Saliwell , Ltd. | QTT | Class II | 2023-12-13 |
| K231803 | Neodent Implant System - Zirconia Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. | NHA | Class II | 2023-12-13 |
| K223340 | EDS Calculus Softener TURBO CR | Essential Dental Systems, Inc. | ELC | Class II | 2023-12-11 |
| K232085 | DVAS (DVAS-M, DVAS-W) | Genoray Co., Ltd. | EHD | Class II | 2023-12-08 |
| K221851 | Lumina-PTFE Titanium | Criteria Industria E Comercio DE Produtos Medicinais | NPK | Class II | 2023-12-08 |
| K232750 | BTI Interna Prosthetic Components | B.T.I. Biotechnology Institute, Sl. | NHA | Class II | 2023-12-08 |
| K231127 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | DZE | Class II | 2023-12-07 |
| K231967 | ARi ExCon Implant System | Megagen Implant Co., Ltd. | DZE | Class II | 2023-12-07 |
| K232220 | SS Abutment System | Osstem Implant Co., Ltd. | NHA | Class II | 2023-12-05 |
| K231817 | AlignerFlow LC | Voco GmbH | DYH | Class II | 2023-12-01 |
| K232438 | Dental Glass Ceramics Blocks | Aibodent Biotechnology Co., Ltd. | EIH | Class II | 2023-12-01 |
| K232418 | Single Platform SP1 Implant System | Southern Implants (Pty), Ltd. | DZE | Class II | 2023-12-01 |
| K230947 | C.A.R.E. Appliance (DNA, mRNA, mmRNA) | Vivos Therapeutics, Inc. | LRK | Class II | 2023-11-28 |
| K232012 | N1 | Osstem Implant Co., Ltd. | EHD | Class II | 2023-11-28 |
| K233171 | PF Keep; Cad Cam Keep Block | Clemde SA DE CV | EBI | Class II | 2023-11-27 |
| K232549 | NemoCast | Software Nemotec S.L. | PNN | Class II | 2023-11-21 |
| K232546 | Meta G UCLA Abutment | Cowellmedi Co., Ltd. | NHA | Class II | 2023-11-21 |
| K233053 | DEXIS Ti2 Intraoral Sensor, DEXIS IXS Size 1 Intraoral Sensor, DEXIS IXS Size 2 Intraoral Sensor | Dental Imaging Technologies Corporation | MUH | Class II | 2023-11-21 |
| K230641 | Ultrasonic Scaler Tips | Guilin Refine Medical Instrument Co., Ltd. | ELC | Class II | 2023-11-21 |
| K231559 | Multi-Unit DAS System | Talladium España, SL | NHA | Class II | 2023-11-17 |
| K223414 | Curing Light, Model: MaxCure 9 | Guilin Refine Medical Instrument Co., Ltd. | EBZ | Class II | 2023-11-15 |
| K232050 | saremco print BRIDGETEC | Saremco Dental AG | EBF | Class II | 2023-11-14 |
| K231097 | Inclusive® Titanium Abutments compatible with: Neoss® ProActive® Narrow, Neoss® ProActive® Standard, MIS® SEVEN®, Zimmer® Eztetic® Implant Systems | Prismatik Dentalcraft, Inc. | NHA | Class II | 2023-11-14 |
| K233434 | Silent Nite® Sleep Appliance with the Glidewell Hinge (SNGLHG) | Prismatik Dentalcraft, Inc. | LRK | Class II | 2023-11-14 |
| K233596 | VarseoSmile TriniQ | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | EBF | Class II | 2023-11-09 |
| K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoit | Micro-Nx Co., Ltd. | EKX | Class I | 2023-11-09 |
| K232076 | Fibercure | Lumendo AG | QNF | Class II | 2023-11-02 |
12,679 clearances in the Dental panel. Data: openFDA.