Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 35
- Latest Decision
- 2017-05-23
Clearances · page 23 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K162598 | HAPI Seal | Bisco, Inc. | EBC | Class II | 2017-05-23 |
| K161689 | OSSTEM Implant System - Abutment | Osstem Implant Co., Ltd. | NHA | Class II | 2017-05-22 |
| K160398 | MRI Compatibility for Existing Zimmer Dental Implant Systems | Zimmer Dental, Inc. | DZE | Class II | 2017-05-17 |
| K170245 | DSM Biomedical Dental Bone Graft | Kensey Nash Corporation Dba Dsm Biomedical | NPM | Class II | 2017-05-16 |
| K163557 | SS SA Fixture | Osstem Implant Co., Ltd. | DZE | Class II | 2017-05-15 |
| K170135 | TREFOIL System | Nobel Biocare AB | DZE | Class II | 2017-05-11 |
| K163131 | A-dec NLZ Electric Motor System | Nakanishi, Inc. | EBW | Class I | 2017-05-11 |
| K163117 | Alpha Pure | Koroad America | NJM | Class II | 2017-05-09 |
| K162734 | CreoDent Solidex Customized Abutment | Creodent Prosthetics, Ltd. | NHA | Class II | 2017-05-08 |
| K162594 | Craniomaxillofacial Distraction System (CMFD) | Synthes USA Products, LLC | MQN | Class II | 2017-05-08 |
| K163238 | Eclipse Kiss Zirconia | Ams | EIH | Class II | 2017-05-04 |
| K163640 | QZA and RS Dental Implant Systems | Trinon Titanium GmbH | DZE | Class II | 2017-05-03 |
| K170733 | ScanX Intraoral View | Duerr Dental AG | MUH | Class II | 2017-05-01 |
| K161857 | Salvin Tenting Screw System | Salvin Dental Specialties | DZL | Class II | 2017-04-28 |
| K170211 | Insight Dental System | Insight Dental System | DZE | Class II | 2017-04-27 |
| K170220 | OneQ-SL s-Clean Implant System | Dentis Co., Ltd. | DZE | Class II | 2017-04-27 |
| K162661 | SavDenTM MTA Root Canal Filling Materials | Tyds Biotech Incorporation | KIF | Class II | 2017-04-25 |
| K160670 | ET US SS Prosthetic system | Osstem Implant Co., Ltd. | NHA | Class II | 2017-04-25 |
| K163088 | TSIII BA Fixture | Osstem Implant Co., Ltd. | DZE | Class II | 2017-04-21 |
| K152830 | K3 | Osstem Implant Co., Ltd. | EIA | Class I | 2017-04-20 |
| K163677 | Ortho System | 3Shape A/S | PNN | Class II | 2017-04-20 |
| K163171 | CeraClean | Bisco, Inc. | PME | Class II | 2017-04-14 |
| K161743 | Etgar Dental Implant System | Etgar Medical Instruments, Ltd. | DZE | Class II | 2017-04-14 |
| K162046 | MINNE TIES MMF Suture System | Summit Medical, Inc. | DYX | Class II | 2017-04-11 |
| K152192 | LED Curing Light | Monitex Industrial Co., Ltd. | EBZ | Class II | 2017-04-07 |
| K170731 | System, X-Ray, Extra oral Source, Digital, PaX-i Plus, PaX-i Insight | VATECH Co., Ltd. | MUH | Class II | 2017-04-04 |
| K163613 | Bluephase Style 20i | Ivoclar Vivadent, AG | EBZ | Class II | 2017-04-04 |
| K162544 | OsteoMed PINNACLE Driver | Osteomed | KMW | Class II | 2017-04-04 |
| K161353 | ESTELITE BULK FILL Flow | Tokuyama Dental Corporation | EBF | Class II | 2017-04-03 |
| K163350 | Multibase Abutments EV and ATLANTIS Suprastructures | Dentsply Sirona | NHA | Class II | 2017-03-31 |
| K162850 | GuideMia Ortho+ | Guidemia Technologies, LLC | PNN | Class II | 2017-03-24 |
| K162028 | PREMIUM - SHELTA Prosthetic Components | Sweden & Martina S.P.A. | NHA | Class II | 2017-03-24 |
| K160581 | K3PRO Konus Additional Abutments and Implants | Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG | DZE | Class II | 2017-03-24 |
| K162967 | nuance UNIVERSAL | Den-Mat Holdings, LLC | EBF | Class II | 2017-03-24 |
| K163175 | Bel-Cypher Pro | Takara Belmont Corporation | MUH | Class II | 2017-03-20 |
| K163346 | MAZIC Duro | Vericom Co., Ltd. | EBF | Class II | 2017-03-17 |
| K162308 | Noris Medical MBI-2mm Dental Implant System | Noris Medical , Ltd. | DZE | Class II | 2017-03-17 |
| K163239 | SMARTmatic | Kaltenbach & Voigt GmbH | EFA | Class I | 2017-03-17 |
| K161077 | RnD TE and RnD SE | Apex Dental Materials, Inc. | KLE | Class II | 2017-03-17 |
| K161416 | Multi-unit Abutment Plus | Nobel Biocare AB | NHA | Class II | 2017-03-16 |
| K161598 | NobelZygoma 0° | Nobel Biocare AB | DZE | Class II | 2017-03-14 |
| K162960 | TotalC-Ram | Itena Clinical | EMA | Class II | 2017-03-14 |
| K162654 | mollosil plus | Detax GmbH & Co. KG | EBI | Class II | 2017-03-13 |
| K163224 | JAZZ SOLO Sensor | Jazz Imaging, LLC | MUH | Class II | 2017-03-09 |
| K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC Temporary Abutments, SC Variobase Abutments, SC CARES Abutment | Straumann USA, LLC | DZE | Class II | 2017-03-08 |
| K162044 | Dentca Denture Base II | Dentca, Inc. | EBI | Class II | 2017-03-03 |
| K160345 | Glass Ionomer Cement | Shandong Huge Dental Material Corporation | EMA | Class II | 2017-03-03 |
| K170420 | n!ce Glass Ceramic Blocks for Amann Girrbach | Institut Straumann AG | EIH | Class II | 2017-03-02 |
| K161655 | On1 Concept | Nobel Biocare AB | NHA | Class II | 2017-02-28 |
| K163282 | Apex Dental Sensors | Masterlink, LLC | MUH | Class II | 2017-02-28 |
| K162888 | Cercon | Dentsply Sirona | EIH | Class II | 2017-02-24 |
| K162073 | Dental Implants OKTAGON Tissue Level and Bone Level | Hager& Meisinger GmbH | DZE | Class II | 2017-02-24 |
| K163480 | Renamel NANO +plus | Cosmedent, Inc. | EBF | Class II | 2017-02-24 |
| K161335 | Dual Top Screw System | Jeil Medical Corporation | OAT | Class II | 2017-02-23 |
| K162926 | Air-Powered Handpieces and Handpiece Attachments | W&H Dentalwerk Burmoos GmbH | EFB | Class I | 2017-02-23 |
| K161500 | MEG-TORQ | Micro-Nx Co., Ltd. | EKX | Class I | 2017-02-22 |
| K161987 | UF(II) Narrow Implant System - Fixture, UF(II) Narrow Implant System - Suprastructure | Dio Corporation | DZE | Class II | 2017-02-21 |
| K163317 | ELECTROmatic | Kaltenbach & Voigt Gmgh | EBW | Class I | 2017-02-21 |
| K160799 | GenNarino | Saliwell , Ltd. | LTF | Class II | 2017-02-17 |
| K162099 | IBS Implant System II | Innobiosurg Co., Ltd. | DZE | Class II | 2017-02-15 |
| K160918 | JUVORA Dental Disc, Ceramill PEEK by JUVORA | Juvora | EBI | Class II | 2017-02-13 |
| K161213 | XSmart iQ | Dentsply Sirona | EBW | Class I | 2017-02-10 |
| K162158 | Porcine Anorganic Bone Mineral in Delivery Applicator | Collagen Matrix, Inc. | NPM | Class II | 2017-02-09 |
| K161980 | Fuselier Intraoral Nighttime Device (FIND) | Fuselier Enterprises, LLC | LRK | Class II | 2017-02-07 |
| K170330 | 3M Protemp Cement Temporary Dental Cement | 3M Company | EMA | Class II | 2017-02-06 |
| K163155 | MTM Clear Aligner | Dentsply Sirona | NXC | Class II | 2017-02-03 |
| K161025 | priti multidisc ZrO2 High Translucent | Pritidenta GmbH | EIH | Class II | 2017-02-03 |
| K161103 | US SA Implant System | Osstem Implant Co., Ltd. | DZE | Class II | 2017-02-02 |
| K162390 | ET Hybrid Abutment | Hiossen, Inc. | NHA | Class II | 2017-01-30 |
| K163689 | 3M Clear Tray Aligner | 3M Unitek Corporation | NXC | Class II | 2017-01-27 |
| K161219 | Zmaxx T Series | Maxx Digm, Inc. | EIH | Class II | 2017-01-26 |
| K163705 | EzRay Air W | VATECH Co., Ltd. | EHD | Class II | 2017-01-24 |
| K162397 | Titan 3 Low Speed Angle Attachments | Dentalez, Inc. | EGS | Class I | 2017-01-19 |
| K163605 | LEDEX WL070+ | Dentmate Technology Co. , Ltd. | EBZ | Class II | 2017-01-19 |
| K161593 | GMI Frontier Dental Implant System | Ilerimplant S.L | DZE | Class II | 2017-01-19 |
| K161762 | DynaMatrix/Dynamatrix Plus | Cook Biotech Incorporated | NPL | Class II | 2017-01-13 |
| K160965 | SuperLine | Dentium Co., Ltd. | DZE | Class II | 2017-01-13 |
| K163519 | RX DC | Cefla S.C. | EHD | Class II | 2017-01-13 |
| K162323 | Tooth Shade Resin Material | Liaoning Upcera Co., Ltd. | EBF | Class II | 2017-01-12 |
| K161281 | Dentalis Bio Solution Implants | Dentalis Bio Solution Implants, LLC | DZE | Class II | 2017-01-11 |
| K162261 | CERAMAGE UP | Shofu Dental Corporation | EBF | Class II | 2017-01-11 |
| K160991 | Neo GBR System | Neobiotech Co., Ltd. | DZL | Class II | 2017-01-10 |
| K160536 | Chaorum Implant System | Medimecca Co., Ltd. | DZE | Class II | 2017-01-05 |
| K161639 | Y-MIC | Micron Corporation | ELC | Class II | 2016-12-22 |
| K161399 | Neocis Guidance System | Neocis, Inc. | PLV | Class II | 2016-12-22 |
| K162436 | EndoVac Pure | Kerr Corporation | NYL | Class I | 2016-12-21 |
| K162677 | L- OVC | Rhondium, Ltd. | EIH | Class II | 2016-12-21 |
| K161197 | Orthodontic Screw | Osstem Implant Co., Ltd. | OAT | Class II | 2016-12-21 |
| K161713 | Dentium CAD/CAM Abutments | Dentium Co., Ltd. | NHA | Class II | 2016-12-16 |
| K162192 | BluePro | Bluesom | LRK | Class II | 2016-12-15 |
| K160798 | IPS e.max® Press Abutment Solutions for Viteo Base Ti | Ivoclar Vivadent, AG | NHA | Class II | 2016-12-15 |
| K160475 | Ritter Dental Implant System | Ritter Implants GmbH & Co. KG | DZE | Class II | 2016-12-14 |
| K161734 | Vanguard Dental Unit | Ritter Concept GmbH | EIA | Class I | 2016-12-09 |
| K161488 | ESTETICA Dental Treatment Unit and Accessories | Kaltenbach & Voigt GmbH | EIA | Class I | 2016-12-08 |
| K161244 | s-Clean OneQ-SL Narrow Implant System | Dentis Co., Ltd. | DZE | Class II | 2016-12-07 |
| K162004 | PREMIUM Implant Systems SHELTA Implant Systems | Sweden & Martina S.P.A. | NHA | Class II | 2016-12-05 |
| K153015 | Transfer & Angled Abutment | Osstem Implant Co., Ltd. | NHA | Class II | 2016-12-05 |
| K160377 | V-varnish Premium | Vericom Co., Ltd. | LBH | Class II | 2016-12-02 |
| K161470 | Internal Distraction - Sterile | KLS Martin L.P. | MQN | Class II | 2016-12-01 |
| K163043 | Zeramex P6 Dental Implant System | Dentalpoint AG | DZE | Class II | 2016-11-30 |
12,679 clearances in the Dental panel. Data: openFDA.