Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 28
- Latest Decision
- 2015-08-26
Clearances · page 27 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K150823 | EDLENi Intra-Oral Sensor | Edlen Imaging, LLC | MUH | Class II | 2015-08-26 |
| K150205 | LED Curing Light | Monitex Industrial Co., Ltd. | EBZ | Class II | 2015-08-24 |
| K150704 | PANAVIA V5: Standard Kit (Universal (A2)), Standard Kit (Clear), Introductory Kit (Universal (A2)), Introductory Kit (Clear), Sample Pack (Universal (A2)), Paste (Universal (A2)), Paste (Clear), Paste (Brown (A4)), Paste (White), Paste (Opaque), Try-in Paste (Universal (A2)), Try-in Paste (Clear), Try-in Paste (Brown (A4)), Try-in Paste (White), Try-in Paste (Opaque), Tooth Primer | Kuraray Noritake Dental, Inc. | EMA | Class II | 2015-08-21 |
| K151087 | CS 8100SC, CS8100SC Access | Trophy | MUH | Class II | 2015-08-21 |
| K142995 | SOPIX | Sopro - Acteon Group | MUH | Class II | 2015-08-17 |
| K151332 | Nexus Universal, Nexus Universal Chroma | Sybron Dental Specialties | EMA | Class II | 2015-08-17 |
| K150432 | IDODENTINE DISC, IDODENTINE BLOCK | Union Dental S.A. | EBG | Class II | 2015-08-14 |
| K150703 | CLEARFIL CERAMIC PRIMER PLUS, CLEARFIL CERAMIC PRIMER PLUS (Trial) | Kuraray Noritake Dental, Inc. | KLE | Class II | 2015-08-13 |
| K151142 | IVOBASE CAD FOR ZENOTEC, IVOBASE CAD BOND, IVOBASE CAD MODELLING LIQUID | Wieland Dental + Technik GmbH & Co. KG | EBI | Class II | 2015-08-13 |
| K150814 | Straumann Screw-Retained Abutment | Straumann USA, LLC | NHA | Class II | 2015-08-10 |
| K151247 | NC Straumann Screw Retained Abutments | Straumann USA, LLC | NHA | Class II | 2015-08-10 |
| K143758 | PerioType Rapid | Clinical House Europe GmbH | DZE | Class II | 2015-08-07 |
| K151157 | NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, NNC Straumann Variobase Abutment for Bars/Bridges, RN Straumann Variobase Abutment for Bars/Bridges, WN Straumann Variobase Abutment for Bars/Bridges | Straumann USA, LLC | NHA | Class II | 2015-08-05 |
| K151023 | COMPACT PIEZO LED | Mectron S.P.A. | ELC | Class II | 2015-08-05 |
| K143292 | TheraCal DC | Bisco, Inc. | EJK | Class II | 2015-08-04 |
| K140432 | HI-LIGHT, HI-LIGHT PLUS | Dentall Corporation | EBZ | Class II | 2015-08-03 |
| K143418 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | EGS | Class I | 2015-07-31 |
| K141970 | DIGITEK TITANIUM ABUTMENT | Digitek Dental Solutions Limited | NHA | Class II | 2015-07-31 |
| K151053 | PSPIX 2 scanner, Imaging Plate Size 0 for PSPIX2 scanner, Imaging Plate Size 1 for PSPIX2 scanner, Imaging Plate Size 2 for PSPIX2 scanner, Imaging Plate Size 3 for PSPIX2 scanner | Sopro - Acteon Group | MUH | Class II | 2015-07-31 |
| K142813 | Biogensis Implant System-Kisses | Biogenesis Co., Ltd. | DZE | Class II | 2015-07-31 |
| K150021 | Z5m(t) | Z-Systems AG | DZE | Class II | 2015-07-31 |
| K142040 | OCS-B COLLAGEN | Nibec Co., Ltd. | NPM | Class II | 2015-07-31 |
| K151150 | Elements | Pac-Dent International, Inc. | ELW | Class II | 2015-07-28 |
| K151045 | TENEO Dental Treatment Unit and Accessories | Sirona Dental Systems GmbH | EIA | Class I | 2015-07-24 |
| K150968 | TRU Dental Implant System | Sterngold Dental, LLC | DZE | Class II | 2015-07-24 |
| K150938 | Straumann® Dental Implant System ¿ Roxolid® SLA Implants | Straumann USA, LLC | DZE | Class II | 2015-07-24 |
| K150344 | Dentis Dental Implant System | Dentis Co., Ltd. | DZE | Class II | 2015-07-24 |
| K143120 | OrthoPulse | Biolux Research , Ltd. | PLH | Class II | 2015-07-24 |
| K150295 | LOCATOR RTx | Zest Anchors, Inc. | NHA | Class II | 2015-07-24 |
| K150601 | Zeramic Adhesive Resin Cement | Premier Dental Company Products | EMA | Class II | 2015-07-22 |
| K151094 | Mosaic Universal Composite | Ultradent Products, Inc. | EBF | Class II | 2015-07-21 |
| K143033 | DENTCA DENTURE BASE | Dentca, Inc. | EBI | Class II | 2015-07-21 |
| K150537 | MiNi Internal Implant System | Megagen Implant Co., Ltd. | DZE | Class II | 2015-07-21 |
| K141777 | NEODENT IMPLANT SYSTEM | Jjgc Industria E Comercio DE Materiais Dentarios S | DZE | Class II | 2015-07-20 |
| K151707 | EzSensor Soft, EzSensor Soft i, EzSensor Bio, and EzSensor Bio i | Rayence Co., Ltd. | MUH | Class II | 2015-07-19 |
| K142651 | The Moses Express appliance | Allen J. Moses, Dds, Ltd. | LRK | Class II | 2015-07-17 |
| K150909 | INTEGO Family and Accesories | Sirona Dental Systems GmbH | EIA | Class I | 2015-07-17 |
| K143011 | 2014 InterActive/SwishActive System | Implant Direct Sybron Manufacturing, LLC | DZE | Class II | 2015-07-16 |
| K150128 | GC Ortho Connect, GC Ortho Etching Gel | Gc Orthodontics America, Inc. | DYH | Class II | 2015-07-16 |
| K150919 | ArgenZ Esthetic Plus | The Argen Corporation | EIH | Class II | 2015-07-13 |
| K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | NHA | Class II | 2015-07-13 |
| K143656 | StarCeram® Z-Nature, StarCeram® Z-Smile | H.C. Starck Ceramics GmbH | EIH | Class II | 2015-07-09 |
| K150933 | iBond Universal & iBond Ceramic Primer | Heraeus Kulzer, LLC, Mitsui Chemicals Group | KLE | Class II | 2015-07-07 |
| K150784 | Admira Fusion | Voco GmbH | EBF | Class II | 2015-07-02 |
| K150296 | Biodenta Customized Abutment-Hybrid | Biodenta Swiss AG | NHA | Class II | 2015-07-02 |
| K150872 | BruxZir Anterior Milling Blanks | Prismatik Dentalcraft, Inc. | EIH | Class II | 2015-07-02 |
| K150750 | Endo 6:1, T1 Line Endo 6 L, SIRONiTi Apex, T1 Spray | Sirona Dental Systems GmbH | EGS | Class I | 2015-07-02 |
| K143411 | TRAUS ENDO | Saeshin Precision Co., Ltd. | EKX | Class I | 2015-06-29 |
| K150363 | NOVA Dental Implants System | Nova Implants , Ltd. | DZE | Class II | 2015-06-29 |
| K143071 | Nacera Pearl | Doceram Medical Ceramics GmbH | EIH | Class II | 2015-06-26 |
| K143505 | Zimmer Patient-Specific Abutment, Internal Hex, Titanium | Zimmer Dental, Inc. | NHA | Class II | 2015-06-25 |
| K150796 | Dental Bone Cutting Instruments | Synthes (USA) Products, LLC | DZJ | Class II | 2015-06-23 |
| K150218 | Fill-Up! | Coltene/Whaledent AG | EBF | Class II | 2015-06-23 |
| K150696 | Jade 37% Phosphoric Acid Etchant Gel | Dharma Research, Inc. | KLE | Class II | 2015-06-23 |
| K150559 | Life Fast Set, Life Regular Set | Sybron Dental Specialties | EJK | Class II | 2015-06-19 |
| K150369 | SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent Fusion (Classic or Flex Retention) with DentiTrac Micro-recorder | Somnomed, Inc. | PLC | Class II | 2015-06-18 |
| K150623 | Nanova Flowable Composite | Nanova Biomaterials, Inc. | EBF | Class II | 2015-06-18 |
| K140836 | ZIBONE ZIRCONIA BLOCKS | Coho Technology Co., Ltd. | EIH | Class II | 2015-06-17 |
| K150727 | ESTECEM | Tokuyama Dental Corporation | EMA | Class II | 2015-06-17 |
| K150535 | Cavitron Touch Ultrasonic Scaling System | Dentsply International, Inc. | ELC | Class II | 2015-06-16 |
| K150199 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | DZE | Class II | 2015-06-15 |
| K143090 | LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID | Talladium, Inc. | EIH | Class II | 2015-06-15 |
| K142751 | Chang Gung ComMed Series Dental Implant System | Chang Gung Medical Technology Co., Ltd. | DZE | Class II | 2015-06-15 |
| K150250 | SternSnap Angled Attachment | Sterngold Dental, LLC | NHA | Class II | 2015-06-11 |
| K143730 | GBR System | Jeil Medical Corporation | JEY | Class II | 2015-06-10 |
| K150393 | TETRIC EVOFLOW BULK FILL | Ivoclar Vivadent, AG | EBF | Class II | 2015-06-09 |
| K140021 | TI-OSS | Chiyewon | NPM | Class II | 2015-06-05 |
| K150012 | CreoDent Solidex Customized Abutment | Creodent Prosthetics, Ltd. | NHA | Class II | 2015-06-04 |
| K142446 | Fixtemp Cement | Exacta Dental Direct, Inc. | EMA | Class II | 2015-06-04 |
| K150076 | Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L | Dong IL Technology , Ltd. | DZI | Class II | 2015-06-02 |
| K141188 | MICRODENT GENIUS IMPLANT SYSTEM | Implant Microdent | DZE | Class II | 2015-06-02 |
| K143524 | Fiber Disks and Blocks (TRINIA) | Bicon, LLC | EBF | Class II | 2015-06-02 |
| K143285 | Mandible External Fixator - MR Conditional | Synthes USA Products, LLC | MQN | Class II | 2015-05-28 |
| K150129 | AEU-7000L-70V IMPLANT/ENDODONTIC DENTAL SYSTEM (LIGHTED VERSION) | Aseptico, Inc. | EKX | Class I | 2015-05-28 |
| K150511 | Coating Material | Sun Medical Co., Ltd. | EBI | Class II | 2015-05-27 |
| K150454 | Acryfree Denture Base Material and Biosens Denture Base Material | Perflex | EBI | Class II | 2015-05-26 |
| K150941 | Somnowell Mandibular Advancement Appliance (MAA) | Somnowell , Ltd. | LRK | Class II | 2015-05-22 |
| K140491 | TANAKA ZIRCOLOR COLORING LIQUID, TANAKA ZIRCOLOR DIPPING LIQUID AND TANAKA ENAMEL ZR BLOCKS | Tanaka Dental | EIH | Class II | 2015-05-20 |
| K143694 | Rhondium One-Visit-Crown(OVC) | Rhondium, Ltd. | EBF | Class II | 2015-05-15 |
| K142729 | Chi Lites Orthodontic Sapphire Bracket | Progressive Technology, Inc. | NJM | Class II | 2015-05-15 |
| K143326 | T.A.G. Dental Implant System | T.A.G. Medical Products Corporation, Ltd. | DZE | Class II | 2015-05-14 |
| K141886 | MDK HANDPIECES | Modern Korea Co., Ltd. | EFB | Class I | 2015-05-13 |
| K142260 | NobelActive | Nobel Biocare AB | DZE | Class II | 2015-05-11 |
| K143667 | GC KommonBase | Gc Orthodontics America, Inc. | DYH | Class II | 2015-05-07 |
| K150056 | Luxisse+ | Heany Industries, Inc. | EIH | Class II | 2015-05-06 |
| K142568 | Stryker MEDPOR TITAN 3D Orbital Floor Implant | Stryker | JEY | Class II | 2015-05-05 |
| K141576 | Maxima PRO 45L | Kavo DO Brasil Industria E Comercio Ltda | EFB | Class I | 2015-05-04 |
| K143212 | Bifix Temp | Voco GmbH | EMA | Class II | 2015-05-01 |
| K143528 | Zimmer Cast-to Gold Abutments for the 3.1mmD Dental Implant System | Zimmer Dental, Inc. | NHA | Class II | 2015-05-01 |
| K143679 | Nuance FLOW | Den-Mat Holdings, LLC | EBF | Class II | 2015-05-01 |
| K150797 | Digital Dental Intra Oral Sensor, EzSensor Smart | Rayence Co., Ltd. | MUH | Class II | 2015-05-01 |
| K143448 | Sonendo GentleWave System | Sonendo, Inc. | ELC | Class II | 2015-05-01 |
| K150798 | Codent Low Speed Dental Handpieces and Accessories | Codent Technical Industry Co., Ltd. | EFB | Class I | 2015-04-24 |
| K142371 | Luminesse PMMA | Talladium, Inc. | EBG | Class II | 2015-04-24 |
| K141482 | KI-20 | Saeyang Microtech Co., Ltd. | EBW | Class I | 2015-04-24 |
| K150182 | Neodent Implant System- CM Drive Implants | Jjgc Industria E Comercio DE Materiais Dentarios S | DZE | Class II | 2015-04-23 |
| K142058 | RAYSCAN A-EXPERT | Ray Co., Ltd. | MUH | Class II | 2015-04-22 |
| K143140 | G-Premio BOND | GC America, Inc. | KLE | Class II | 2015-04-20 |
| K150490 | UnicLine Mobile | Heka Dental A/S | EIA | Class I | 2015-04-17 |
| K143591 | Dorsal Appliance | Gergens Orthodontic Lab | LRK | Class II | 2015-04-15 |
12,679 clearances in the Dental panel. Data: openFDA.