Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 34
- Latest Decision
- 2018-10-11
Clearances · page 20 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K180249 | OmniPore DUROMAX Surgical Implants | Matrix Surgical Holdings, LLC/Matrix Surgical USA | JEY | Class II | 2018-10-11 |
| K182070 | BioHorizons Tapered IM Implants | BioHorizons Implant Systems, Inc. | DZE | Class II | 2018-10-10 |
| K173945 | Straumann SC Variobase Abutments | Institut Straumann AG | NHA | Class II | 2018-10-05 |
| K181138 | IS-III active System | Neobiotech Co., Ltd. | DZE | Class II | 2018-10-03 |
| K180998 | BioHorizons CAD/CAM Bars | BioHorizons Implant Systems, Inc. | NHA | Class II | 2018-09-28 |
| K181476 | Prime&Bond active Universal Adhesive | Dentsply Sirona | KLE | Class II | 2018-09-28 |
| K180241 | Orthocaps Twinaligner | Ortho Caps GmbH | NXC | Class II | 2018-09-28 |
| K180803 | BeautiBond Universal | Shofu Dental Corporation | KLE | Class II | 2018-09-26 |
| K173141 | CSM Submerged3-L Implant System | Csm Implant | DZE | Class II | 2018-09-19 |
| K182206 | RiX70 DC | Trident S.R.L | EHD | Class II | 2018-09-13 |
| K181241 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | DZJ | Class II | 2018-09-13 |
| K181236 | HySil Impression Materials | Osstem Implant Co., Ltd. | ELW | Class II | 2018-09-13 |
| K171532 | TruBase S | Truabutment, Inc. | NHA | Class II | 2018-09-11 |
| K181504 | Stryker Pediatric Mandibular Distractor 2 | Stryker | MQN | Class II | 2018-09-11 |
| K180465 | Provata Implant System | Southern Implants (Pty), Ltd. | DZE | Class II | 2018-09-06 |
| K181167 | Upcera Glaze Paste, Glaze Powder, and Glaze Liquid | Liaoning Upcera Co., Ltd. | EIH | Class II | 2018-09-02 |
| K181482 | myTAP2 | Airway Management, Inc. | LRK | Class II | 2018-08-31 |
| K180185 | BIO-C REPAIR | Angelus Industria DE Produtos Odontologicos S/A | KIF | Class II | 2018-08-31 |
| K180536 | Neodent Implant System GM Line | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | DZE | Class II | 2018-08-30 |
| K173623 | Anchor plate | Biomaterials Korea, Inc. | OAT | Class II | 2018-08-30 |
| K180802 | Meta P&Bond | Meta Biomed Co., Ltd. | KLE | Class II | 2018-08-29 |
| DEN170090 | MATRx plus | Zephyr Sleep Technologies | QCJ | Class II | 2018-08-23 |
| K173784 | Smylic Invisible Clear Aligners | Smylio, Inc. | NXC | Class II | 2018-08-23 |
| K170050 | Z-CAD smile | Metoxit AG | EIH | Class II | 2018-08-23 |
| K181312 | GrandioSO x-tra | Voco GmbH | EBF | Class II | 2018-08-22 |
| K171377 | Young INFINITY Cordless Handpiece System | Young Dental Manufacturing Co. 1, LLC | EKX | Class I | 2018-08-20 |
| K173257 | BTI Dental Implant System UnicCa | B.T.I. Biotechnology Institute, Sl. | DZE | Class II | 2018-08-17 |
| K173608 | Forest Dental Unit | Forest Dental Products, Inc. | EIA | Class I | 2018-08-17 |
| K173575 | OsteoReady Dental Implant System | Osteoready, LLC | DZE | Class II | 2018-08-17 |
| K180619 | Bongo | Innomed Healthscience, Inc. | OHP | Class II | 2018-08-16 |
| K181500 | BRILLIANT Crios | Coltene/Whaledent AG | EBF | Class II | 2018-08-15 |
| K181359 | InterActive SMARTBase Abutments | Implant Direct Sybron Manufacturing, LLC | NHA | Class II | 2018-08-15 |
| K180962 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | JEY | Class II | 2018-08-13 |
| K181891 | Portable X-ray System (Model: MiniX-V, Mini X-S) | Digimed Co., Ltd. | EHD | Class II | 2018-08-10 |
| K173819 | MyPlant II Implant System | Hager& Meisinger GmbH | DZE | Class II | 2018-08-09 |
| K180598 | UNIQA Dental Implants System | Uniqa Dental, Ltd. | DZE | Class II | 2018-08-08 |
| K180703 | VITA YZ ST and VITA YZ XT | Vita Zahnfabrik H.Rauter GmbH Co. | EIH | Class II | 2018-08-01 |
| K173943 | Dental High-speed Handpiece and Accessories | Microp Technology (Taiwan), Inc. | EFB | Class I | 2018-07-24 |
| K181178 | S-mini active Fixture | Neobiotech Co., Ltd. | DZE | Class II | 2018-07-24 |
| K173188 | The Graft Natural Bone Substitute | Purgo Biologics, Inc. | NPM | Class II | 2018-07-20 |
| K181636 | Aurora | Sodium Systems, LLC | MUH | Class II | 2018-07-20 |
| K181189 | ATLANTIS Conus Structure | Dentsply Sirona | NHA | Class II | 2018-07-18 |
| K173968 | Straumann Variobase for Bridge/Bar Cylindrical | Institut Straumann AG | NHA | Class II | 2018-07-17 |
| K181011 | AIM2 | GC America, Inc. | ELW | Class II | 2018-07-12 |
| K180613 | Estelite Universal Flow | Tokuyama Dental Corporation | EBF | Class II | 2018-07-12 |
| K172543 | High-speed Turbine Handpieces for Single Use | Beijing Dongbo Dental Handpiece Co., Ltd. | EFB | Class I | 2018-07-11 |
| K173039 | TruMatch CMF Titanium 3D Printed Implant | Materialise NV | JEY | Class II | 2018-07-10 |
| K172991 | Advanced Dental Applicance | Dasoft Partners | LRK | Class II | 2018-07-10 |
| K173562 | Straumann Jason Membrane | Institut Straumann AG | NPL | Class II | 2018-07-09 |
| K172952 | Figaro Crowns Anterior Crown Kit, Figaro Crowns Posterior Crown Kit | Figaro Crowns, Inc. | EBF | Class II | 2018-07-03 |
| K171197 | Zuga Dental Implant System | Zuga Medical, Inc. | DZE | Class II | 2018-06-30 |
| K173116 | KJ ZIRCONIA Implant System | Kj Meditech Co., Ltd. | DZE | Class II | 2018-06-28 |
| K180562 | TEMP BASIC, TEMP PREMIUM, TEMP PREMIUM FLEXIBLE, MULTISTRATUM FLEXIBLE, THERAPON, TRY-IN, BURNOUT, TRY-IN & BURNOUT | Zirkonzahn GmbH | EBG | Class II | 2018-06-28 |
| K173856 | Express 4 Sleep appliance/CPAP Sidekick appliance | Moses Appliances, LLC | LRK | Class II | 2018-06-26 |
| K180282 | MIS Internal Hex Dental Implant System | Mis Implants Technologies , Ltd. | DZE | Class II | 2018-06-22 |
| K181358 | Televere Digital Dental Imaging System | Televere Systems, Inc. | MUH | Class II | 2018-06-20 |
| K173905 | Surgic Pro, Surgic Pro+ | Nakanishi, Inc. | EBW | Class I | 2018-06-19 |
| K172345 | IU Implant System | Warantec Co., Ltd. | DZE | Class II | 2018-06-18 |
| K181484 | Tecno Med, Tecno Med Mineral, Tecno Med Mineral Dentine, Tecno Med Mineral Tissue | Zirkonzahn Srl | EBF | Class II | 2018-06-18 |
| K173908 | DESS Dental Smart Solutions | Terrats Medical SL | NHA | Class II | 2018-06-15 |
| K181271 | Signature Orthodontic System | Signature Orthodontics | NJM | Class II | 2018-06-13 |
| K180565 | PEAK NS033CF, PEAK NS017CF | Neosil Co., Ltd. | ELW | Class II | 2018-06-13 |
| K180124 | ZQuiet | Sleeping Well, LLC | LRK | Class II | 2018-06-12 |
| K172821 | Ti-one 101 TS Dental Implant System | Hung Chun Bio-S Co., Ltd. | DZE | Class II | 2018-06-11 |
| K180649 | BeautiCem Veneer Kit | Shofu Dental Corporation | EBF | Class II | 2018-06-11 |
| K173706 | Piccolo Implants and Accessories | Southern Implants (Pty), Ltd. | DZE | Class II | 2018-06-08 |
| K173573 | Tetric CAD | Ivoclar Vivadent, AG | EBF | Class II | 2018-06-07 |
| K173961 | Straumann BLX Implant System | Institut Straumann AG | DZE | Class II | 2018-06-05 |
| K180608 | Lunoa System | Nightbalance BV | MYB | Class II | 2018-06-05 |
| K172765 | Smart Moves Complete | Great Lakes Orthodontics, Ltd. | NXC | Class II | 2018-06-01 |
| K173975 | UF(II) Wide Fixture | Dio Corporation | DZE | Class II | 2018-06-01 |
| K173157 | Dr's Light2 | Good Doctors Co., Ltd. | EBZ | Class II | 2018-05-29 |
| K170697 | GBR system | Surgident | JEY | Class II | 2018-05-24 |
| K173938 | IS-III HActive Fixture | Neobiotech Co., Ltd. | DZE | Class II | 2018-05-24 |
| K180609 | Rodo Smilekey | Rodo Medical, Inc. | NHA | Class II | 2018-05-23 |
| K172430 | ArgenIS Titanium Abutments | Argen Corporation | NHA | Class II | 2018-05-18 |
| K180527 | IS3 | Hiossen, Inc. | EKX | Class I | 2018-05-16 |
| K171449 | Metacem | Meta Biomed Co., Ltd. | EMA | Class II | 2018-05-15 |
| K172640 | Dentium Implantium & SuperLine Prosthetics | Dentium Co., Ltd. | NHA | Class II | 2018-05-14 |
| K180360 | OKTAGON Implant System | Hager& Meisinger GmbH | DZE | Class II | 2018-05-10 |
| K180386 | Meron Plus QM | Voco GmbH | EMA | Class II | 2018-05-08 |
| K162021 | 3.0 Dynamic TiBase | Talladium Espana, SL | NHA | Class II | 2018-05-04 |
| K172100 | URIS OMNI System | Truabutment, Inc. | DZE | Class II | 2018-05-04 |
| K172137 | PIEZOTOME CUBE | Satelec - Acteon Group | DZI | Class II | 2018-05-03 |
| K171007 | Fluorescence Mode | Carl Zeiss Suzhou Co., Ltd. | NBL | Class II | 2018-05-03 |
| K172764 | Keymill | Mycone Dental Supply Company, Inc. (Aka Keystone Industries) | EBI | Class II | 2018-04-27 |
| K171872 | P50 Series Dental Operative Unit and Accessories | Pelton & Crane | EIA | Class I | 2018-04-26 |
| K180252 | Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank | Crown Porcelain Dental Technology Co., Ltd. | EIH | Class II | 2018-04-24 |
| K173902 | Neodent Implant System GM Line | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | NHA | Class II | 2018-04-20 |
| K171562 | Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono | Dreve Dentamid GmbH | ELW | Class II | 2018-04-13 |
| K171326 | Piezosurgery White | Mectron S.P.A. | DZI | Class II | 2018-04-13 |
| K172047 | Riva Star | Sdi Limited | PHR | Class II | 2018-04-11 |
| K170776 | DTI-1 SLA IMPLANT SYSTEM | Dti Implant Sistemleri Sanayi Ticaret Anonim Sirketi | DZE | Class II | 2018-04-10 |
| K171409 | OT EQUATOR | Rhein'83 Srl | NHA | Class II | 2018-04-09 |
| K162408 | Nano Varnish, Plaquit, Lightpaint on Surface | Dreve Dentamid GmbH | EBD | Class II | 2018-04-05 |
| K173207 | SIC invent Dental Implant Systems | Sic Invent AG | DZE | Class II | 2018-04-05 |
| K180344 | TheraCal DC | Bisco, Inc. | EJK | Class II | 2018-04-05 |
| K180561 | MobileX Portable X-ray System | Denterprise International, Inc. | EHD | Class II | 2018-04-04 |
| K172630 | Kisses Plus Implant System | Achimhai Medical Corporation | DZE | Class II | 2018-04-03 |
| K172382 | GC Fuji Direct | GC America, Inc. | EMA | Class II | 2018-04-02 |
12,679 clearances in the Dental panel. Data: openFDA.