Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 33
- Latest Decision
- 2023-06-22
Clearances · page 9 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K231202 | QuickRayPRO | Denterprise International, Inc. | MUH | Class II | 2023-06-22 |
| K223083 | Straumann SLActive labeling changes | Institut Straumann AG | DZE | Class II | 2023-06-22 |
| K223029 | Perfit CL | Vatech Mcis Co., Ltd. | EIH | Class II | 2023-06-20 |
| K223535 | SMARTbase Abutment System | Implant Direct Sybron Manufacturing, LLC | NHA | Class II | 2023-06-20 |
| K220907 | The iNAP One Sleep Therapy System | Somnics, Inc. | OZR | Class II | 2023-06-16 |
| K222144 | IR SLA Type Implant System | Biotem Co., Ltd. | DZE | Class II | 2023-06-14 |
| K223517 | Clear Aligner | Wuxi EA Medical Instruments Technologies Limited. | NXC | Class II | 2023-06-13 |
| K223518 | iOrtho | Shanghai EA Medical Instruments Co., Ltd. | PNN | Class II | 2023-06-13 |
| K231347 | BruxZir TintEFX Coloring Liquid | Prismatik Dentalcraft, Inc. | EIH | Class II | 2023-06-09 |
| K230905 | OrthoPulse 2.0E (OPi2E-100) | Biolux Technology GmbH | PLH | Class II | 2023-06-09 |
| K222792 | SNUCONE Tissue Level Implant System | Snucone Co., Ltd. | DZE | Class II | 2023-06-08 |
| K231635 | A-Line Advanced | Biocetec Co., Ltd. | NJM | Class II | 2023-06-06 |
| K230225 | DynaFlex Clear Brackets & Buttons | Dyna Flex | NJM | Class II | 2023-06-05 |
| K221752 | Stella | Shinhung Mst Co., Ltd. | DZE | Class II | 2023-06-04 |
| K230888 | Titanium Turbine | Nakanishi, Inc. | EFB | Class I | 2023-06-02 |
| K222961 | Harvest Conceal ZR Block Out | Harvest Dental Products, LLC | EIH | Class II | 2023-06-02 |
| K231259 | iRoot SP Plus | Innovative Bioceramix, Inc. | KIF | Class II | 2023-05-31 |
| K223814 | Genesis ACTIVE Implant System | Keystone Dental, Inc. | DZE | Class II | 2023-05-25 |
| K230246 | Dentis s-Clean SQ-SL Narrow Implant System | Dentis Co., Ltd. | NHA | Class II | 2023-05-25 |
| K222891 | Dental Desensitizer | Guangzhou Beogene Biotech Co., Ltd. | LBH | Class II | 2023-05-25 |
| K230259 | Soreal Press, Soreal CAD | Shenzhen Up3D Technology Co., Ltd. | EIH | Class II | 2023-05-25 |
| K223663 | SIMDA Abutment | Simda Co., Ltd. | NHA | Class II | 2023-05-24 |
| K230106 | General Cutting Straight | Nakanishi, Inc. | EGS | Class I | 2023-05-24 |
| K230523 | s-Clean Link Abutment Narrow | Dentis Co., Ltd. | NHA | Class II | 2023-05-24 |
| K231464 | 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) | 3M Company, Unitek Orthodontic Products | NXC | Class II | 2023-05-22 |
| K230465 | Hi-Bond Universal | Mediclus Co., Ltd. | KLE | Class II | 2023-05-22 |
| K220829 | Endo Motor | Foshan Coxo Medical Instrument Co., Ltd. | EKX | Class I | 2023-05-18 |
| K222560 | BlueCheck Caries Detection & Monitoring | Incisive Technologies Pty, Ltd. | LFC | Class II | 2023-05-16 |
| K230262 | BruxZir Incisal Coloring Liquid | Prismatik Dentalcraft, Inc. | EIH | Class II | 2023-05-16 |
| K231391 | Combi Touch | Mectron S.P.A. | ELC | Class II | 2023-05-15 |
| K222836 | Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs | Institut Straumann AG | NHA | Class II | 2023-05-15 |
| K221969 | IU Implant System Abutment | Warantec Co., Ltd. | NHA | Class II | 2023-05-12 |
| K223706 | PMMA BLOCK | Huliang(Shanghai) Bio-Tech Co., Ltd. | EBG | Class II | 2023-05-12 |
| K222489 | Harvest Printable Resin | Harvest Dental Products, LLC | EBI | Class II | 2023-05-12 |
| K222549 | OpenTex | Purgo Biologics, Inc. | NPK | Class II | 2023-05-11 |
| K223624 | Emerald Herbst | Island Dental Lab, Inc Dba Emerald Dental | LRK | Class II | 2023-05-10 |
| K231338 | 3M Clinpro Clear 2.1% Sodium Fluoride Treatment | 3M Espe Dental Products | LBH | Class II | 2023-05-10 |
| K202963 | ELEC Master, ELEC Master Dual | Mgnewton , Ltd. | EIA | Class I | 2023-05-05 |
| K222847 | Ceramic Brackets Orthometric | Orthometric - Industria E Comercio DE Produtos Medicos | NJM | Class II | 2023-05-04 |
| K230203 | Dentis I-FIX Abutment | Dentis Co., Ltd. | NHA | Class II | 2023-05-03 |
| K223182 | Arial Dental, Mistral Dental Amalgam, World Work Dental Amalgam, BMS Non Gamma 2 Alloy, Flexi Alloy, Hi-S Alloy, WW Dental Amalgam, Hi - Mix, Non Gamma 2 Alloy | Worldwork S.R.L | OIV | Class II | 2023-05-01 |
| K223677 | Titanium Abutment Blank Nobel Biocare N1 TCC | Nobel Biocare AB | NHA | Class II | 2023-04-28 |
| K222636 | ET Abutment System | Hiossen, Inc. | NHA | Class II | 2023-04-28 |
| K223634 | Customized Abutment | Arum Dentistry Co., Ltd. | NHA | Class II | 2023-04-28 |
| K223892 | DentMix VPS Impression Material | Innovative Product Brands, Inc. | ELW | Class II | 2023-04-27 |
| K222548 | Endo Motor | Shenzhen Perfect Medical Instruments Co., Ltd. | EKX | Class I | 2023-04-26 |
| K230218 | DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) | Dental Direkt GmbH | NHA | Class II | 2023-04-25 |
| K223141 | STR8 Clear Aligner | Str8 Oral Care | NXC | Class II | 2023-04-24 |
| K230103 | Klockner Abutments | SOADCO, S.L. | NHA | Class II | 2023-04-24 |
| K230811 | Digital Intraoral X-Ray Sensor | Iray Imaging Technology (Haining) Limited | MUH | Class II | 2023-04-21 |
| K223454 | Custom-made Invisible Aligners | Zhejiang Yinchili Medical Technology Co., Ltd. | NXC | Class II | 2023-04-17 |
| K222469 | TIB Abutments | Southern Implants (Pty), Ltd. | NHA | Class II | 2023-04-17 |
| K230098 | Trusana | Myerson, LLC | EBI | Class II | 2023-04-13 |
| K230010 | ADSEAL Plus | Meta Biomed Co., Ltd. | KIF | Class II | 2023-04-13 |
| K230143 | DESS Dental Smart Solutions | Terrats Medical SL | NHA | Class II | 2023-04-13 |
| K222738 | Point implant system | Pointnix Co., Ltd. | DZE | Class II | 2023-04-13 |
| K230732 | Eagle S/Saevo Slim/D700 Slim | Alliage S/A Industrias Medica Odontológico. | MUH | Class II | 2023-04-11 |
| K230069 | S.I.N. Dental Implant System | S.I.N. Sistema DE Implante Nacional S.A. | NHA | Class II | 2023-04-06 |
| K230341 | ACRIFIX | Deltamed GmbH | EBI | Class II | 2023-04-06 |
| K221537 | Nightwear Aligners | Smylio, Inc. | NXC | Class II | 2023-04-05 |
| K211556 | N2 | Megagen Implant Co., Ltd. | EIA | Class I | 2023-04-05 |
| K213749 | G7, Dental Operative Unit and Accessories | Shinhung Company, Ltd. | EIA | Class I | 2023-04-03 |
| K230003 | Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Topzir Biotech Co., Ltd. | EIH | Class II | 2023-03-31 |
| K223192 | XT Stain/Glaze | Shenzhen Xiangtong Co., Ltd. | EIH | Class II | 2023-03-27 |
| K223365 | RODIN Palette Naturalizing Kit | Belport Company, Inc., Gingi-Pak | EBD | Class II | 2023-03-27 |
| K230797 | SmartMTA Capsule | Sprig Oral Health Technologies, Inc. | KIF | Class II | 2023-03-24 |
| K222096 | Endo Ultrasonic Activator | Foshan Coxo Medical Instrument Co., Ltd. | ELC | Class II | 2023-03-23 |
| K212394 | Implant-One Multi-Unit Abutment | Implant Logistics, Inc. | NHA | Class II | 2023-03-23 |
| K222367 | SAVE GBR | Dentis Co., Ltd. | DZL | Class II | 2023-03-23 |
| K221402 | CEREC Tessera Abutment Block, CEREC Tessera Abutment System | Dentsply Sirona, Inc. | NHA | Class II | 2023-03-22 |
| K221808 | InterOss Collagen | Sigmagraft, Inc. | NPM | Class II | 2023-03-18 |
| K230115 | Denture Base Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | EBI | Class II | 2023-03-17 |
| K222619 | Ensmile | Ensmile Pvt, Ltd. | NXC | Class II | 2023-03-16 |
| K221301 | DESS Dental Smart Solutions | Terrats Medical SL | NHA | Class II | 2023-03-09 |
| K223742 | Dental Ceramic Blocks | Aidite (Qinhuangdao) Technology Co., Ltd. | EBF | Class II | 2023-03-08 |
| K223024 | MedCAD AccuPlan System | Medcad | DZJ | Class II | 2023-03-07 |
| K222445 | LC ChromeFlow | S&C Polymer Silicon- Und Composite Spezialitaten GmbH | EBF | Class II | 2023-03-06 |
| K222457 | Provata Implant System | Southern Implants (Pty), Ltd. | DZE | Class II | 2023-03-06 |
| K221587 | DHX-70H, XTG-70H | Digimed Co., Ltd. | EHD | Class II | 2023-03-03 |
| K230009 | EZ Bond Universal | Meta Biomed Co., Ltd. | KLE | Class II | 2023-03-03 |
| K223253 | Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) | Arum Dentistry Co., Ltd. | EIH | Class II | 2023-02-27 |
| K221845 | Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G | Blue Sky Bio, LLC | NXC | Class II | 2023-02-24 |
| K211554 | InnoGenic Non-resorbable Membrane | Cowellmedi Co., Ltd. | NPK | Class II | 2023-02-24 |
| K221741 | TRAUS Air Dental Handpiece | Saeshin Precision Co., Ltd. | EFB | Class I | 2023-02-22 |
| K223477 | PMMA Blocks for Dental Use | Aidite (Qinhuangdao) Technology Co., Ltd. | EBG | Class II | 2023-02-16 |
| K213757 | Endocem MTA Premixed Regular | Maruchi | KIF | Class II | 2023-02-14 |
| K223194 | Glass Ceramic | Shenzhen Xiangtong Co., Ltd. | EIH | Class II | 2023-02-10 |
| K222513 | Glass Ceramics | Yilink (Tianjin) Biotechnology Co., Ltd. | EIH | Class II | 2023-02-10 |
| K223338 | Toothsi, Smilealigners | Makeo Healthcare Technologies Private Limited | NXC | Class II | 2023-02-09 |
| K222451 | SAVE GBR | Dentis Co., Ltd. | NHA | Class II | 2023-02-07 |
| K230095 | ScanX Swift 2.0, ScanX Swift View 2.0 | Durr Dental SE | MUH | Class II | 2023-02-06 |
| K230270 | 3M VitCal Liner/Base | 3M Espe Dental Products | EJK | Class II | 2023-02-06 |
| K223395 | Luna Dental Implant System | Shinhung Mst Co., Ltd. | NHA | Class II | 2023-02-03 |
| K222211 | Implant Direct Dental Implant Systems Portfolio - MR Conditional | Implant Direct Sybron Manufacturing, LLC | DZE | Class II | 2023-02-02 |
| K213175 | No Stress Impress | No Stress Impress, LLC | ELW | Class II | 2023-01-19 |
| K223446 | eXciteOSA without remote control (3000); eXciteOSA with remote control (6000) | Signifier Medical Technologies, Ltd. | QNO | Class II | 2023-01-18 |
| K223010 | Portable X-ray System | Iray Technology Taicang , Ltd. | EHD | Class II | 2023-01-17 |
| K214078 | Silkn Toothwave | Home Skinovations , Ltd. | QMJ | Class II | 2023-01-13 |
| K221317 | S-Mono | Shinhung Mst Co., Ltd. | DZE | Class II | 2023-01-13 |
| K222913 | s-Clean Link Abutment | Dentis Co., Ltd. | NHA | Class II | 2023-01-13 |
12,679 clearances in the Dental panel. Data: openFDA.