Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 30
- Latest Decision
- 2020-06-25
Clearances · page 16 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K192221 | Legacy2, Legacy3, Legacy4, simplyLegacy2, simplyLegacy3 dental implants; Legacy2, Legacy3, Legacy4 fixture-mounts | Implant Direct Sybron Manufacturing, LLC | DZE | Class II | 2020-06-25 |
| K201668 | VarseoSmile Crown plus | Bego Bremer Goldschlägerei Wilh. Herbst GmbH & Co. KG | EBF | Class II | 2020-06-23 |
| K200772 | ULab Systems uDesign Software | Ulab Systems, Inc. | PNN | Class II | 2020-06-23 |
| K190637 | Fit & Brilliant Dental Implant System | F&B Technology Co., Ltd. | DZE | Class II | 2020-06-19 |
| K191913 | TruAbutment DS | Truabutment, Inc. | NHA | Class II | 2020-06-19 |
| K193234 | NUVO IF Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | DZE | Class II | 2020-06-18 |
| K192274 | BV Dental Implant System | Bio Concept Co., Ltd. | DZE | Class II | 2020-06-18 |
| K192747 | Yxoss CBR® | Reoss GmbH | JEY | Class II | 2020-06-17 |
| K200131 | BruxZir Steel | Prismatik Dentalcraft, Inc. | EIH | Class II | 2020-06-10 |
| K181813 | ImmersiveView Surgical Plan (IVSP®) | Immersivetouch | DZJ | Class II | 2020-06-09 |
| K200753 | IBS Implant System II | Innobiosurg Co., Ltd. | NHA | Class II | 2020-06-09 |
| K192033 | Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC Tip, Contour P-Insert Quad Tip | Bennett Jacoby, Dds, Ms, Inc. | DZI | Class II | 2020-06-09 |
| K193003 | NemoCast | Software Nemotec S.L. | PNN | Class II | 2020-06-05 |
| K192262 | Dental Zirconia Blocks | De Corematrix Co., Ltd. | EIH | Class II | 2020-05-29 |
| K192392 | DiaPlus | DiaDent Group International | KLE | Class II | 2020-05-26 |
| K193460 | The iNAP One Sleep Therapy System | Somnice, Inc. | OZR | Class II | 2020-05-26 |
| K181691 | High-speed air turbine handpiece / Low-speed air turbine handpiece | Foshan Wenjian Medical Instrument Co., Ltd. | EFB | Class I | 2020-05-26 |
| K200662 | X-Guide® Surgical Navigation System | X-Nav Technologies, LLC | PLV | Class II | 2020-05-21 |
| K193553 | VarseoSmile Temp | Bego Bremer Goldschlagerei Wilh. Herbst GmbH & Co. KG | EBG | Class II | 2020-05-18 |
| K193404 | UF(II) Bar holder abutment | Dio Corporation | NHA | Class II | 2020-05-18 |
| K193436 | VITA Ambria | Vita Zahnfabrik GmbH H Rauter & CO | EIH | Class II | 2020-05-14 |
| K193096 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | DZE | Class II | 2020-05-14 |
| K193055 | Purzir Dental Zirconia | 3DBiocad | EIH | Class II | 2020-05-13 |
| K192244 | Arcad SmileStudio and Aligner System | Arcadlab | NXC | Class II | 2020-05-11 |
| K200348 | Neocis Guidance System (NGS) with Fiducial Array Splint (FAS) | Neocis, Inc. | PLV | Class II | 2020-05-08 |
| K192218 | Custom Legacy and Custom InterActive Titanium Abutments | Implant Direct Sybron Manufacturing, LLC | NHA | Class II | 2020-05-08 |
| K192651 | ZAGA Zygomatic System | Southern Implants (Pty), Ltd. | DZE | Class II | 2020-05-07 |
| K193496 | CharmFil | Dentkist, Inc. | EBF | Class II | 2020-05-06 |
| K192069 | Aerodentis System | Dror Orthodesign | NXC | Class II | 2020-05-06 |
| K201184 | Lascod Impression Materials | Lascod Spa | ELW | Class II | 2020-05-05 |
| K191590 | AA temp temporary restoration 3D printing photoreactive resin | Enlighten Materials Co., Ltd. | EBG | Class II | 2020-05-05 |
| K193592 | Neodent Implant System - Change in the Shelf Life of Neodent Acqua Implants | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | DZE | Class II | 2020-04-28 |
| K200867 | Implantswiss Dental Implant System and Implantswiss Dental Abutment System | Novodent SA | DZE | Class II | 2020-04-28 |
| K192197 | Magicore II System | Innobiosurg Co., Ltd. | DZE | Class II | 2020-04-28 |
| K193388 | GlassLok Kits, GlassLok Powder, GlassLok Liquid | Reliance Orthodontic Products, Inc. | DYH | Class II | 2020-04-27 |
| K190139 | Zircos-Com | Bioden Co., Ltd. | EBF | Class II | 2020-04-24 |
| K191308 | U-Aligner | Universal Orthodontic Laboratory, Inc. | NXC | Class II | 2020-04-23 |
| K191997 | FAICO CMF System | Faico Medical, LLC | JEY | Class II | 2020-04-22 |
| K192701 | DIBS (Digital Indirect Bonding System) | Orthoselect, LLC | PNN | Class II | 2020-04-21 |
| K191720 | BRUIS Software Suite | Mechanodontics, Inc. | PNN | Class II | 2020-04-17 |
| K193588 | DD Contrast | Dental Direkt GmbH | EIH | Class II | 2020-04-16 |
| K200625 | I-View Gold and Imagen Gold Dental Sensors | Trident S.R.L | MUH | Class II | 2020-04-15 |
| K200099 | s-Clean SQ-SL Implant System Mini | Dentis Co., Ltd. | DZE | Class II | 2020-04-13 |
| K190353 | Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac | Residential Home Sleep Services | PLC | Class II | 2020-04-10 |
| K192108 | Panthera Dental Milled Bars | Panthera Dental, Inc. | NHA | Class II | 2020-04-08 |
| K192401 | Straumann Screw-Retained Abutments | Straumann USA, LLC | NHA | Class II | 2020-04-06 |
| K192015 | Faico Dental Implant System | Faico Medical, LLC | DZE | Class II | 2020-04-03 |
| K193390 | CS Model+ | Trophy | PNN | Class II | 2020-04-02 |
| K200188 | DSI Dental Implant System | Dsi Dental Solutions, Ltd. | DZE | Class II | 2020-04-01 |
| K200040 | Universal Base Conical Connection (CC) | Nobel Biocare AG | NHA | Class II | 2020-03-30 |
| K200294 | GrandioSO Light Flow | Voco GmbH | EBF | Class II | 2020-03-27 |
| K190091 | Diapaste | DiaDent Group International | KIF | Class II | 2020-03-27 |
| K193136 | Stryker Customized Mandible Recon Plate Kit | Stryker | JEY | Class II | 2020-03-26 |
| K193143 | Stryker Facial iD Plating System | Stryker | JEY | Class II | 2020-03-26 |
| K193078 | MIS CONNECT Conical Connection System | Dentsply Sirona | NHA | Class II | 2020-03-25 |
| K192284 | DiaFil Flow | DiaDent Group International | EBF | Class II | 2020-03-25 |
| K193335 | Sherlock | Open Implants, LLC | NHA | Class II | 2020-03-24 |
| K191838 | Clearform Aligners | Motor City Lab Works | NXC | Class II | 2020-03-20 |
| K193659 | iTero Element 5D | Align Technology, Inc. | NTK | Class II | 2020-03-20 |
| K192510 | DIAFIL & DIAFIL Capsule | DiaDent Group International | EBF | Class II | 2020-03-20 |
| K192007 | TheraBase, TheraBase Ca | Bisco, Inc. | EMA | Class II | 2020-03-17 |
| K192338 | NEOLab Clear Aligners | New England Ortho Lab, Inc. | NXC | Class II | 2020-03-12 |
| K193447 | Vista Dyes | Inter-Med/Vista Dental Products | LFC | Class II | 2020-03-11 |
| K193425 | Pre-Milled Blank | Arum Dentistry Co., Ltd. | NHA | Class II | 2020-03-09 |
| K193529 | ATLANTIS Abutment for MIS Conical Connection Implants | Dentsply Sirona | NHA | Class II | 2020-03-05 |
| K191991 | Ezfil | Meta Biomed Co., Ltd. | EBF | Class II | 2020-03-05 |
| K190509 | Lubrina 2 | J. Morita USA, Inc. | EFB | Class I | 2020-03-04 |
| K193064 | Atlantis suprastructures | Dentsply Sirona, Inc. | NHA | Class II | 2020-03-03 |
| K200284 | R-Sensor, R-Sensor | Remedi Co., Ltd. | MUH | Class II | 2020-02-28 |
| K193274 | Rodo Abutment System | Rodo Medical, Inc. | NHA | Class II | 2020-02-27 |
| K190919 | ST Internal Implant System | T-Plus Implant Tech. Co., Ltd. | DZE | Class II | 2020-02-27 |
| K200189 | Luna Dental Implant System- Healing Abutment | Shinhung Mst Co., Ltd. | NHA | Class II | 2020-02-26 |
| K192192 | VSP System | 3D Systems | DZJ | Class II | 2020-02-26 |
| K191389 | Allcem Veneer APS | Dentscare Ltda | EBF | Class II | 2020-02-25 |
| K200214 | 3D Predict | 3D Smile USA, Inc. | NXC | Class II | 2020-02-24 |
| K200148 | LightForce Orthodontic System (LFO System) | Lightforce Orthodontics | NJM | Class II | 2020-02-21 |
| K191728 | ULTepap Expiratory Positive Airway Pressure (EPAP) Device | Bryggs Medical, LLC | OHP | Class II | 2020-02-21 |
| K192263 | UCLA CCM Abutment | Dio Corporation | NHA | Class II | 2020-02-21 |
| K190641 | AR_N SLA Type Implant System | Biotem Co., Ltd. | DZE | Class II | 2020-02-21 |
| K191719 | X-MIND Trium | De Gotzen S.R.L. | MUH | Class II | 2020-02-20 |
| K190406 | SDS2.2 dental implant | Sds Swiss Dental Solutions AG | DZE | Class II | 2020-02-20 |
| K192381 | DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor | Scientific Pharmaceuticals | LBH | Class II | 2020-02-18 |
| K191737 | The Graft Bone Substitute | Purgo Biologics, Inc. | NPM | Class II | 2020-02-14 |
| K192614 | Meg-Ball Attachment System, Meg-Loc Abutment, Meg-Magnet Abutment | Megagen Implant Co., Ltd. | NHA | Class II | 2020-02-13 |
| K192233 | LED Curing Light | Foshan Cicada Dental Instrument Co, Ltd. | EBZ | Class II | 2020-02-13 |
| K192022 | DiaTemp Flow | DiaDent Group International | EBG | Class II | 2020-02-13 |
| K192158 | DiaTemp | DiaDent Group International | EBG | Class II | 2020-02-13 |
| K183024 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | DZE | Class II | 2020-02-13 |
| K191453 | Cervitec F | Ivoclar Vivadent, AG | LBH | Class II | 2020-02-11 |
| K192596 | ULab Systems Dental Aligner Kit | Ulab Systems, Inc. | NXC | Class II | 2020-02-11 |
| K200182 | EzRay Air Portable (Model: VEX-P300) | VATECH Co., Ltd. | EHD | Class II | 2020-02-11 |
| K191919 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | NHA | Class II | 2020-02-10 |
| K192846 | Argen Clear Aligner, Argen Clear Aligner Premium | Argen Corporation | NXC | Class II | 2020-02-10 |
| K190192 | K3Pro Konus New Abutments and Implants | Argon Med. Productions Vertriebs Gesellschaft Mbh CO KG | DZE | Class II | 2020-02-10 |
| K192273 | DIAETCH Economic Package Type A, DIATECH Regular Package, DIAETCH Refill Package Type A, DIAETCH Intro Kit | DiaDent Group International | KLE | Class II | 2020-02-07 |
| K191890 | Elos Accurate Customized Abutment | Elos Medtech Pinol A/S | NHA | Class II | 2020-02-06 |
| K180935 | Infinity / Infinity Cross Flex Dental Systems | Olsen Industria E Comercio S.A. | EIA | Class I | 2020-02-05 |
| K192127 | Respire Pink AT (Hard, Hard/Soft, EF) | Respire Medical Holdings | LRK | Class II | 2020-02-05 |
| K192806 | DENTCA Crown and Bridge | Dentca, Inc. | EBG | Class II | 2020-02-05 |
| K192688 | s-Clean SQ-SL Implant System Regular | Dentis Co., Ltd. | DZE | Class II | 2020-02-04 |
12,679 clearances in the Dental panel. Data: openFDA.