Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 30
- Latest Decision
- 2020-02-03
Clearances · page 17 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K192579 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | PLV | Class II | 2020-02-03 |
| K192535 | Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia | Qinhuangdao Audental Metal Technology Co., Ltd. | EIH | Class II | 2020-01-31 |
| K192941 | HySil Super Fast Impression Materials | Osstem Implant Co., Ltd. | ELW | Class II | 2020-01-30 |
| K193060 | Noritake Super Porcelain EX-3 | Kuraray Noritake Dental, Inc. | EIH | Class II | 2020-01-30 |
| K191926 | VITA VIONIC Bond | Vita Zanhnfabrik H. Rauter GmbH Co. | EBI | Class II | 2020-01-29 |
| K183106 | TruAbutment DS | Truabutment, Inc. | NHA | Class II | 2020-01-29 |
| K191837 | UniSmile Clear Aligner System | Vitang Technology, LLC | NXC | Class II | 2020-01-29 |
| K192581 | The NightBlocks Appliance | Advanced Facialdontics, LLC | LQZ | Class II | 2020-01-28 |
| K190271 | FiteBac Cavity Cleanser | Largent Health, LLC | LBH | Class II | 2020-01-23 |
| K192530 | Surefil one Self-adhesive Composite Hybrid | Dentsply Sirona | EMA | Class II | 2020-01-23 |
| K192436 | Healing Abutments and Cover Screws | Dentium Co., Ltd. | NHA | Class II | 2020-01-23 |
| K190837 | Internal Hex Implant System | Ebi, Inc. | DZE | Class II | 2020-01-22 |
| K190871 | Bio-TackS Orthodontic Mini Implant | Biocetec Co., Ltd. | OAT | Class II | 2020-01-17 |
| K192251 | Livento Press, Soprano 10, Soprano | Cendres+Metaux SA | EIH | Class II | 2020-01-15 |
| K192409 | Midwest Rhino XE and Air Motor M | Dentsply Sirona | EFB | Class I | 2020-01-13 |
| K191221 | Cybird LED Curing Light | Dxm Co., Ltd. | EBZ | Class II | 2020-01-10 |
| K192009 | LED Curing Light | Ezgo Group, Inc. | EBZ | Class II | 2020-01-09 |
| K192767 | Clear Aligner | Royal Dental Lab | NXC | Class II | 2020-01-08 |
| K192412 | SD500 Elite LubeFree High Speed Handpiece, SD500 Elite Lubricated High Speed Handpiece, SD500 Pro LubeFree High Speed Handpiece, Pro Lubricated High Speed Handpiece | Dentalez, Inc. | EFB | Class I | 2020-01-06 |
| K191123 | Multi-unit Abutments | Medentika GmbH | NHA | Class II | 2020-01-06 |
| K192893 | Straumann Ceramic Healing Abutments | Institut Straumann AG | NHA | Class II | 2020-01-03 |
| K193239 | MPowRx Snoring Solution (also known as Good Morning Snore Solution) | Mpowrx Health and Wellness Products 2012, Inc. | LRK | Class II | 2020-01-03 |
| K190243 | Z5-BL | Z-Systems AG | DZE | Class II | 2020-01-03 |
| K192457 | Elos Accurate Customized Abutment | Elos Medtech Pinol A/S | NHA | Class II | 2020-01-02 |
| K192655 | Depuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | JEY | Class II | 2019-12-30 |
| K191256 | Straumann BLX Ø3.5 mm Implants | Institut Straumann AG | DZE | Class II | 2019-12-27 |
| K192700 | Xcam | Hdx Will Corp. | EHD | Class II | 2019-12-27 |
| K192178 | R&D Series Nova Compo N | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | EBF | Class II | 2019-12-20 |
| K190112 | Non-Sterile Zirconia Block | Fine Advanced Compound Co., Ltd. | EIH | Class II | 2019-12-20 |
| K192470 | DenMat Orthodontic Aligners | Denmat Holdings, LLC | NXC | Class II | 2019-12-20 |
| K191823 | Clear-Aligners | Cdb Corporation | NXC | Class II | 2019-12-20 |
| K182388 | Krystal Klear Aligners | Shatkin F.I.R.S.T., LLC | NXC | Class II | 2019-12-19 |
| K192229 | Neodent Implant System- GM Titanium Base for Bridge | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | NHA | Class II | 2019-12-19 |
| K190935 | EZER, Portable X-ray System | Livermoretech, Inc. | EHD | Class II | 2019-12-19 |
| K191306 | Llis, Vittra APS | Dentscare Ltda | EBF | Class II | 2019-12-16 |
| K190394 | SunClear Aligner system | Sun Dental Laboratories, LLC | NXC | Class II | 2019-12-16 |
| K191751 | EM Provisional | Hiossen, Inc. | DZE | Class II | 2019-12-16 |
| K183424 | Ambar, Ambar APS, Ambar Universal APS | Dentscare Ltda | KLE | Class II | 2019-12-13 |
| K190537 | BIO-C Sealer Ion+ | Angelus Industria DE Produtos Odontologicos S/A | KIF | Class II | 2019-12-12 |
| K192149 | MIS Dental Implant System | Dentsply Sirona, Inc. | DZE | Class II | 2019-12-11 |
| K191618 | SleepTight Mouthpiece STZ | Michael D Williams Dds PA | LRK | Class II | 2019-12-11 |
| K190508 | EVO 450 series High Speed Handpieces | Ttbio Corp. | EFB | Class I | 2019-12-11 |
| K181900 | Dental high speed handpiece, Dental low speed handpiece | Foshan Cicada Dental Instrument Co, Ltd. | EFB | Class I | 2019-12-09 |
| K191054 | Southern Implants MAX Implant System | Southern Implants (Pty), Ltd. | DZE | Class II | 2019-12-09 |
| K191895 | Straumann Mini Implants | Institut Straumann AG | DZE | Class II | 2019-12-09 |
| K192522 | TSV BellaTek Express and BellaTek Flex Abutments | Biomet 3i, LLC | NHA | Class II | 2019-12-09 |
| K190552 | JJ Implant System | Jj Implants | DZE | Class II | 2019-12-06 |
| K191250 | Southern Implants PEEK Abutments | Southern Implants (Pty), Ltd. | NHA | Class II | 2019-12-05 |
| K192766 | Digital Intraoral Imaging Plate System | Fsusen Technology Co., Ltd. | MUH | Class II | 2019-12-05 |
| K191191 | Neodent Implant System - Temporary Abutments | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | NHA | Class II | 2019-12-05 |
| K182758 | MCI - CMF System | Mci Medical Concept Innovation, Inc. | JEY | Class II | 2019-12-05 |
| K191656 | Zipbond | Sdi Limited | KLE | Class II | 2019-12-02 |
| K191911 | 3Shape Splint Design | 3Shape A/S | PNN | Class II | 2019-11-27 |
| K182892 | TRAUS Dental Handpieces | Saeshin Precision Co., Ltd. | EGS | Class I | 2019-11-26 |
| K182712 | DEXIS CariVu 3-in-1 by KaVo | Kaltenbach & Voigt GmbH | NTK | Class II | 2019-11-23 |
| K191903 | BruxZir GT (Gum Tissue) Color | Prismatik Dentalcraft, Inc. | EIH | Class II | 2019-11-22 |
| K191028 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | JEY | Class II | 2019-11-22 |
| K190518 | Color Liquid, Vita Liquid | Zirkonzahn Srl | EIH | Class II | 2019-11-22 |
| K191103 | Parkell Desensitizer Gel | Parkell, Inc. | EJK | Class II | 2019-11-22 |
| K192260 | everX Flow | GC America, Inc. | EBF | Class II | 2019-11-22 |
| K181953 | SDS1.2 dental implant | Sds Swiss Dental Solutions AG | DZE | Class II | 2019-11-20 |
| K191865 | SmartLite Pro Modular LED Curing Light | Dentsply Sirona | EBZ | Class II | 2019-11-20 |
| K182917 | FluoroCal | Bisco, Inc. | LBH | Class II | 2019-11-18 |
| K191980 | CLEARFIL MAJESTY ES Flow | Kuraray Noritake Dental, Inc. | EBF | Class II | 2019-11-18 |
| K191201 | EM SA Implant System | Hiossen, Inc. | DZE | Class II | 2019-11-15 |
| K182672 | ROSA Bracket | Gni Co., Ltd. | NJM | Class II | 2019-11-15 |
| K192347 | ST Internal Implant System | Megagen Implant Co., Ltd. | DZE | Class II | 2019-11-14 |
| K192202 | Clear21 | World Class Technology Corporation | NJM | Class II | 2019-11-12 |
| K191986 | DESS Dental Smart Solutions | Terrats Medical SL | NHA | Class II | 2019-11-10 |
| K190958 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | DZE | Class II | 2019-11-09 |
| K191527 | Visalys CemCore, Visalys Cem Core Try In Paste | Kettenbach GmbH & Co. KG | EMA | Class II | 2019-11-08 |
| K190998 | BA Pit & Fissure Sealant | Apex Dental Materials, Inc. | EBC | Class II | 2019-11-08 |
| K190571 | StoneBite and StoneBite scan | Dreve Dentamid GmbH | ELW | Class II | 2019-11-07 |
| K192153 | Portux CAD/CAM Disc | New Stetic, SA | EBG | Class II | 2019-11-07 |
| K190003 | Vivid Aligners | Orthodent Laboratory, Inc. | NXC | Class II | 2019-11-06 |
| K182929 | BIO-RAY A-1 Anchor Screw System | Microware Precision Co., Ltd. | OAT | Class II | 2019-11-06 |
| K192992 | Suglue 3 | 3M Deutschland GmbH | EMA | Class II | 2019-11-05 |
| K191304 | EthanZir Zirconia | Besorah Dental Solutions NZ Limited | EIH | Class II | 2019-11-04 |
| K190608 | Mei Ceramic Bracket | Orthosun Co., Ltd. | NJM | Class II | 2019-11-04 |
| K191634 | Scan Abutments and Comfort Caps | Dentium Co., Ltd. | NHA | Class II | 2019-11-04 |
| K183465 | Allcem, Allcem Core | Dentscare Ltda | EMA | Class II | 2019-11-02 |
| K191631 | ZMAXX Dental Zirconia Blanks | Zmaxx Bioceramics, LLC | EIH | Class II | 2019-11-01 |
| K191497 | NextDent Denture 3D+ | Vertex-Dental B.V. | EBI | Class II | 2019-11-01 |
| K183018 | VPro5 | Propel Orthodontics, LLC | OYH | Class II | 2019-11-01 |
| K192961 | ADH19 | 3M Deutschland GmbH | KLE | Class II | 2019-10-31 |
| K191385 | BRILLIANT COMPONEER | Coltene/Whaledent AG | EBF | Class II | 2019-10-29 |
| K192053 | W Zirconia Implants | Tav Medical , Ltd. | DZE | Class II | 2019-10-29 |
| K192029 | Straumann PUREloc abutments | Institut Straumann AG | NHA | Class II | 2019-10-28 |
| K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One | E.M.S Electro Medical Systems S.A | ELC | Class II | 2019-10-20 |
| K191902 | Razor, Everest, U&C Liquid | U&C International Co., Ltd. | EIH | Class II | 2019-10-11 |
| K191548 | Nexus Universal Self-Cure | Kerr Corporation | EMA | Class II | 2019-10-11 |
| K191458 | Legacy SMARTBase Abutments | Implant Direct Sybron Manufacturing, LLC | NHA | Class II | 2019-10-10 |
| K191523 | Visalys Restorative Primer | Kettenbach GmbH & Co. KG | KLE | Class II | 2019-10-09 |
| K182448 | AnyRidge Octa 1 Implant System | Megagen Implant Co., Ltd. | DZE | Class II | 2019-10-09 |
| K191127 | Advanced Intermezzo Implant System | Megagen Implant Co., Ltd. | DZE | Class II | 2019-10-08 |
| K191133 | KATANA Cleaner, KATANA Cleaner (Trial) | Kuraray Noritake Dental, Inc. | PME | Class II | 2019-10-08 |
| K191843 | Ceramill A-Temp | Amann Girrbach AG | EBG | Class II | 2019-10-04 |
| K190940 | Tokuyama Rebase III | Tokuyama Dental Corporation | EBI | Class II | 2019-10-04 |
| K191794 | Vintage Art Universal | Shofu Dental Corporation | EIH | Class II | 2019-10-03 |
| K182143 | ALFA GATE Dental Implants System | Alfa Gate Mazen, Ltd. | DZE | Class II | 2019-10-03 |
12,679 clearances in the Dental panel. Data: openFDA.