Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 30
- Latest Decision
- 2019-04-01
Clearances · page 19 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K181597 | Le'Pen | Kmihh, Ltd. | EBZ | Class II | 2019-04-01 |
| K182609 | Delphos Implants Rigid Fixation System | Delphos Implants - Ind.Com. Importacao E Exportacao DE | JEY | Class II | 2019-03-29 |
| K180924 | Reflect Implant System | Ids - Integrated Dental Systems | DZE | Class II | 2019-03-29 |
| K181858 | Electric Handpiece Motor | W&H Dentalwerk Buermoos GmbH | EBW | Class I | 2019-03-26 |
| K183408 | Jensen Shade Effect Liquids | Jensen Industries, Inc. | EIH | Class II | 2019-03-20 |
| K183518 | Preat Abutments | Preat Corporation | NHA | Class II | 2019-03-18 |
| K190359 | Sonendo GentleWave System | Sonendo, Inc. | ELC | Class II | 2019-03-16 |
| K190357 | Star-X, Intraoral X-ray System | Hdx Will Corp. | EHD | Class II | 2019-03-15 |
| K183380 | Tetric PowerFill | Ivoclar Vivadent, AG | EBF | Class II | 2019-03-14 |
| K183113 | DePuy Synthes Maxillofacial Portfolio - MR Conditional | Synthes (USA) Products, LLC | MQN | Class II | 2019-03-13 |
| K182789 | KLS Martin Individual Patient Solutions (IPS) Planning System | KLS-Martin L.P. | DZJ | Class II | 2019-03-11 |
| K182313 | BoneTrust Implant System | Medical Instinct Deutschland GmbH | DZE | Class II | 2019-03-11 |
| K173064 | ZAPnea Oral Appliance | B. Fareid, Dds, PC | LRK | Class II | 2019-03-08 |
| K183147 | BrackFix | Voco GmbH | DYH | Class II | 2019-03-01 |
| K181932 | DTX Studio design | Nobel Biocare AB | PNP | Class II | 2019-03-01 |
| K190234 | ODI HD Dental Sensor | Cnd Global Technologies, Inc. | MUH | Class II | 2019-03-01 |
| K180682 | AeroPro Cordless Prophy System | Premier Dental Company Products | EKX | Class I | 2019-02-27 |
| K173418 | NobelParallel Conical Connection | Nobel Biocare AB | DZE | Class II | 2019-02-21 |
| K180953 | AnyCheck IMT-100 | Dms Co., Ltd. | EKX | Class I | 2019-02-20 |
| K180346 | Byte Aligner System | Straight Smile, LLC | NXC | Class II | 2019-02-19 |
| K182293 | OsseOne Dental Implant System | Synoross Dba Osseone | DZE | Class II | 2019-02-15 |
| K183569 | DD cube ONE ML | Dental Direkt GmbH | EIH | Class II | 2019-02-14 |
| K182661 | Kava and Kava with Herbst | Sketchpad Innovations, LLC | LRK | Class II | 2019-02-13 |
| K183637 | Cruxcan (CRX-1000) | Cruxell Corp. | MUH | Class II | 2019-02-12 |
| K180691 | TrueDorsal Devices | True Function Laboratory, Inc. | LRK | Class II | 2019-02-11 |
| K182833 | ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer | The Argen Corporation | EIH | Class II | 2019-02-08 |
| K181142 | Absoanchor Microimplant | Dentos, Inc. | OAT | Class II | 2019-02-05 |
| K182198 | Panoura X-ERA PF/NF/MF | The Yoshida Dental Mfg. Co., Ltd. | MUH | Class II | 2019-01-31 |
| K181129 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | EGS | Class I | 2019-01-31 |
| K181580 | Cortex CAD/CAM Abutments | Cortex Dental Implants Industries , Ltd. | NHA | Class II | 2019-01-29 |
| K182228 | MIS LOCKiT Abutments System, OT-Equators and Ball Attachments | Mis Implants Technologies , Ltd. | NHA | Class II | 2019-01-28 |
| K182642 | GenesisZr 4Y Zirconia | United Dental Resources Corporation | EIH | Class II | 2019-01-25 |
| K182312 | Zyppah Anti-Snoring Device | Always More Marketing | LRK | Class II | 2019-01-24 |
| K180183 | Ritter Dental Implant System | Ritter Implants GmbH & Co. KG | DZE | Class II | 2019-01-24 |
| K182193 | S-Line | Biocetec Co., Ltd. | NJM | Class II | 2019-01-22 |
| K182620 | MRI Compatibility for Existing Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | DZE | Class II | 2019-01-18 |
| K181917 | MTA2.3 MATERIALS | NuSmile, Ltd. | KIF | Class II | 2019-01-11 |
| K182202 | SLEEPAPP | Comfort Acrylics, Inc. | LRK | Class II | 2019-01-11 |
| K182869 | Fit SA | Shofu Dental Corporation | EBF | Class II | 2019-01-09 |
| K180648 | Park Dental Research Aligners | Park Dental Research Corporation | NXC | Class II | 2019-01-08 |
| K182305 | Stryker Facial iD Plating System | Stryker | JEY | Class II | 2019-01-07 |
| K180564 | Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases | Medentika GmbH | NHA | Class II | 2019-01-07 |
| K180199 | BIO-C TEMP | Angelus Industria DE Produtos Odontologicos S/A | KIF | Class II | 2019-01-04 |
| K180477 | Straumann PURE Ceramic Implant System | Institut Straumann AG | DZE | Class II | 2019-01-04 |
| K183643 | Clear Image Aligners | Specialty Appliance Works, Inc. | NXC | Class II | 2019-01-03 |
| K183542 | Signature Orthodontic System | Signature Orthodontics | NJM | Class II | 2019-01-02 |
| K183476 | 3M Filtek Universal Restorative | 3M Espe Dental Products | EBF | Class II | 2019-01-02 |
| K180204 | CranioMaxillofacial Fixation (CMF) System - CMF Visionare | Visionare, LLC | JEY | Class II | 2018-12-28 |
| K181703 | Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments | Institut Straumann AG | DZE | Class II | 2018-12-28 |
| K181331 | JUVORA Oyster White Dental Disc, CERAMILL PEEK by JUVORA, Oyster White | Juvora, Ltd. | EBI | Class II | 2018-12-21 |
| K182776 | Neocis Guidance System | Neocis, Inc. | PLV | Class II | 2018-12-21 |
| K181037 | DIO CAD/CAM Abutment | Dio Corporation | NHA | Class II | 2018-12-21 |
| K181496 | VINTAGE PRO | Shofu Dental Corporation | EIH | Class II | 2018-12-18 |
| K182422 | Lucitone Denture Base Materials | Dentsply Sirona | EBI | Class II | 2018-12-18 |
| K182194 | UV Active Implant System | Dio Corporation | DZE | Class II | 2018-12-14 |
| K182296 | HyperFil-LV | Parkell, Inc. | EBF | Class II | 2018-12-14 |
| K182065 | EVOLUX CAD/CAM PMMA BLOCKS | Blue Dent Dental | EBG | Class II | 2018-12-13 |
| K182068 | Erran Dental Zirconia | Hangzhou Erran Technology Co., Ltd. | EIH | Class II | 2018-12-13 |
| K180859 | PYRAMIDION Dental Implants and Prostheses | Dentack Implants, Ltd. | DZE | Class II | 2018-12-13 |
| K180578 | Harvest Dental Polymer Blocks | Harvest Dental Products, LLC | EBG | Class II | 2018-12-12 |
| K181869 | On1 Universal Abutment | Nobel Biocare AB | NHA | Class II | 2018-12-12 |
| K180657 | Resin for Temporary Crown & Bridge | Dentis Co., Ltd. | EBG | Class II | 2018-12-07 |
| K181107 | Elevo® Kit Snoring Intervention Device | Zelegent, Inc. | LRK | Class II | 2018-12-06 |
| K183069 | NobelZygoma 0° | Nobel Biocare AB | DZE | Class II | 2018-12-04 |
| K181816 | Ceramic Denture Zirconia Ceramics Block | Qinhuangdao Silide Ceramic Technology Co., Ltd. | EIH | Class II | 2018-11-29 |
| K173701 | Implant-One System | Implant Logistics, Inc. | DZE | Class II | 2018-11-29 |
| K181604 | Sildent Fast Light Body, Sildent Fast Heavy Body, Sildent Bite | Hrs Co., Ltd. | ELW | Class II | 2018-11-28 |
| K183159 | 3M Clarity Aligners | 3M Company | NXC | Class II | 2018-11-26 |
| K181112 | Orchestrate 3D | Orchestrate 3D | PNN | Class II | 2018-11-26 |
| K181381 | A.B. Dental Devices Dental Implants System | A.B. Dental Device , Ltd. | NHA | Class II | 2018-11-23 |
| K181123 | ApnoDent Appliance | Apnomed, Inc. | LRK | Class II | 2018-11-21 |
| K181297 | DENTIOIII series (DENTIOIII, DENTIOIII-S) | Hdx Will Corp. | MUH | Class II | 2018-11-21 |
| K182288 | TPH Spectra ST Flowable Composite Restorative | Dentsply Sirona | EBF | Class II | 2018-11-20 |
| K180917 | GC Acrylic Primer | GC America, Inc. | KLE | Class II | 2018-11-20 |
| K181396 | Oral Device OA, Oral Device S | Passion For Life Healthcare (Uk) Limited | LRK | Class II | 2018-11-16 |
| K180184 | Zeramex(R) XT Dental Implant System, NobelPearl Dental Implant System | Dentalpoint AG | NHA | Class II | 2018-11-16 |
| K181137 | IT-III active System | Neobiotech Co., Ltd. | DZE | Class II | 2018-11-16 |
| K173971 | K2 Zirkon Blank white classic; K2 Zirkon Blank translucent; K2 Blanks extreme translucent | Yeti Dentalprodukte GmbH | EIH | Class II | 2018-11-15 |
| K181689 | Nexcomp | Meta Biomed Co., Ltd. | EBF | Class II | 2018-11-15 |
| K181850 | Inversa Implants | Southern Implants (Pty), Ltd. | DZE | Class II | 2018-11-14 |
| K180463 | Apoller Flow Light Cure Flowable Composite | Greenway Yw, LLC | EBF | Class II | 2018-11-14 |
| K182338 | Blue Sky Bio Computerized Orthodontic Bracket System | Blue Sky Bio | DYW | Class II | 2018-11-09 |
| K182329 | SureCure Orthodontic Aligner System | Digital Orthodontic Care | NXC | Class II | 2018-11-08 |
| K182162 | OptiBond eXTRa Universal | Kerr Corporation | KLE | Class II | 2018-11-07 |
| K172668 | W Zirconia Implants | Tav Medical , Ltd. | DZE | Class II | 2018-11-06 |
| K180838 | SaliPen | Saliwell , Ltd. | LTF | Class II | 2018-11-06 |
| K181266 | Implantswiss Dental Implant System, Implantswiss Dental Abutment System | Novodent SA | DZE | Class II | 2018-11-01 |
| K180899 | Universal Base Abutment | Nobel Biocare AB | NHA | Class II | 2018-10-31 |
| K171585 | LUXEN Zr, LUXEN Smile | Dentalmax Co., Ltd. | EIH | Class II | 2018-10-31 |
| K180718 | ORTHODONTIC PLASTIC BRACKETS AND ACCESSORIES | Tomy, Inc. | DYW | Class II | 2018-10-30 |
| K170732 | Biomate Dental Implant System | Biomate Medical Devices Technology Co., Ltd. | DZE | Class II | 2018-10-26 |
| K181739 | Invisalign System with Mandibular Advancement Feature | Align Technology, Inc. | NXC | Class II | 2018-10-26 |
| K181922 | Sonendo Material A | Sonendo, Inc. | KIF | Class II | 2018-10-22 |
| K173594 | Straumann cerabone | Institut Straumann AG | NPM | Class II | 2018-10-19 |
| K180941 | Ortho System | 3Shape A/S | PNN | Class II | 2018-10-17 |
| K181910 | BracePaste MTP Light Cure Primer | American Orthodontics | KLE | Class II | 2018-10-15 |
| K181220 | Juell 3D Volo Base | Park Dental Research Corporation | EBI | Class II | 2018-10-12 |
| K173920 | LS OIL | J. Morita USA, Inc. | EKX | Class I | 2018-10-11 |
| K181520 | Sirona Dental CAD/CAM System | Dentsply Sirona | NHA | Class II | 2018-10-11 |
| K182826 | Ormco Spark Aligner System | Sybron Dental Specialties | NXC | Class II | 2018-10-11 |
12,679 clearances in the Dental panel. Data: openFDA.