Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 31
- Latest Decision
- 2016-01-29
Clearances · page 26 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K151194 | KLOCKNER DENTAL IMPLANT ABUTMENTS (II) | SOADCO, S.L. | NHA | Class II | 2016-01-29 |
| K152188 | QUAD Dental Implants and Prostheses | Dentack Impants, Ltd. | DZE | Class II | 2016-01-28 |
| K150672 | VistaCam iX Proof | Durr Dental AG | NBL | Class II | 2016-01-27 |
| K152520 | Magicore System | Innobiosurg Co., Ltd. | DZE | Class II | 2016-01-25 |
| K151996 | TAURUS C1 | Shinhung Company, Ltd. | EIA | Class I | 2016-01-22 |
| K152100 | Evogue Dental Unit | Takara Belmont Corporation | EIA | Class I | 2016-01-22 |
| K152215 | DENTALOS PLUS MONO, DENTALOS PLUS MULTICOLOR | Dentalplus GmbH | EBG | Class II | 2016-01-19 |
| K151039 | ATLANTIS Abutment for NobelActive 3.0 | Dentsply International, Inc. | NHA | Class II | 2016-01-14 |
| K151842 | Rainbow Shine | Genoss | EIH | Class II | 2016-01-14 |
| K151846 | Rainbow LS Pressing | Genoss | EIH | Class II | 2016-01-14 |
| K151621 | BioHorizons CAD/CAM Abutments | BioHorizons Implant Systems, Inc. | NHA | Class II | 2016-01-13 |
| K152509 | CAMLOG and CONELOG Abutments for Screw-retained Restorations (ASR) | Altatec GmbH | NHA | Class II | 2016-01-12 |
| K151328 | PURE Ceramic Implants | Straumann USA | DZE | Class II | 2016-01-11 |
| K152392 | VINTAGE LD | Shofu Dental Corporation | EIH | Class II | 2016-01-08 |
| K143445 | Tellos ISQ Buddy | Tellos Medical AB | EKX | Class I | 2016-01-07 |
| K150585 | Ascent 3D | CAO Group, Inc. | EBZ | Class II | 2015-12-31 |
| K152373 | VITA VM LC Flow | Vita Zahnfabrik H.Rauter GmbH & Co. | EBF | Class II | 2015-12-30 |
| K152162 | Myray- HYPERION X5 | Cefla S.C. | MUH | Class II | 2015-12-24 |
| K151916 | TRI Dental Implant System | Tri Dental Implants Int. AG | DZE | Class II | 2015-12-18 |
| K152322 | Resolve 2.0 | Denali Corporation | PME | Class II | 2015-12-16 |
| K152118 | Zenostar MT, Zenostar Color Liquids | Wieland Dental + Technik GmbH & Co. KG | EIH | Class II | 2015-12-16 |
| K151926 | QuickRay HD Intraoral Sensor | Denterprise International, Inc. | MUH | Class II | 2015-12-14 |
| K152451 | VINTAGE Art LF | Shofu Dental Corporation | EIH | Class II | 2015-12-11 |
| K152326 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | JEY | Class II | 2015-12-10 |
| K151699 | BEAUTIFIL II Enamel | Shofu Dental Corporation | EBF | Class II | 2015-12-10 |
| K150079 | Regenomer® Syringe, Regenomer® Plug, Regenomer® Block | Nibec Co., Ltd. | NPM | Class II | 2015-12-10 |
| K142313 | OneQ-SL Implant System | Dentis Co., Ltd. | DZE | Class II | 2015-12-10 |
| K152243 | One Coat 7 Universal | Coltene/Whaledent AG | KLE | Class II | 2015-12-09 |
| K152146 | High Speed Handpieces and Accessories | Codent Technical Industry Co., Ltd. | EFB | Class I | 2015-12-08 |
| K152292 | Respire Blue Series-EF | Respire Medical Holding | LRK | Class II | 2015-12-07 |
| K152175 | Upcera Dental Zirconia Blank for Aesthetic Restoration | Liaoning Upcera Co., Ltd. | EIH | Class II | 2015-12-04 |
| K152859 | Portable X-ray System (Model: MINIX-V / MINIX-S) | Digimed Co., Ltd. (Digimed Corporation Until 31/12/2012) | EHD | Class II | 2015-12-03 |
| K151295 | Biodenta Customized Abutment - Titanium | Biodenta Swiss AG | NHA | Class II | 2015-12-01 |
| K152518 | Vonflex S Putty | Vericom Co., Ltd. | ELW | Class II | 2015-11-30 |
| K152779 | Avex CX2 | Opal Orthodontics by Ultradent Products | NJM | Class II | 2015-11-25 |
| K142211 | OT EQUATOR | Rhein'83 Srl | NHA | Class II | 2015-11-25 |
| K133178 | LUXATOR LX HANDPIECE | Directa AB | EGS | Class I | 2015-11-24 |
| K151764 | YAMAHACHI PMMA DISKS | Yamahachi Dental Products USA, Inc. | EBG | Class II | 2015-11-23 |
| K143704 | Advanced Air System | W&H Dentalwerk Buermoos GmbH | EFB | Class I | 2015-11-23 |
| K152349 | Star+ VPS Scannable Impression Material | Danville Materials, LLC | ELW | Class II | 2015-11-23 |
| K150571 | 3i T3 Short Implants | Biomet 3i | DZE | Class II | 2015-11-20 |
| K152110 | e-1 etchants | E Dental Products | KLE | Class II | 2015-11-20 |
| K151344 | Cytoflex Tefguard Ti-Enforced Membrane | Unicare Biomedical, Inc. | NPK | Class II | 2015-11-19 |
| K143630 | Invisalign System | Align Technology, Inc. | NXC | Class II | 2015-11-18 |
| K152004 | Nanova Universal Composite | Nanova Biomaterials, Inc. | EBF | Class II | 2015-11-17 |
| K151798 | Inclusive Titanium Abutments compatible with: Straumann synOcta Implant System | Prismatik Dentalcraft, Inc. | NHA | Class II | 2015-11-16 |
| K152936 | Sirius Max Dental Diode Curing Light | National Dental, Inc. | EBZ | Class II | 2015-11-13 |
| K152270 | Denture base resin | Korea Engineering Plastics Co., Ltd. | EBI | Class II | 2015-11-13 |
| K150388 | Dental Implant System | Bio Concept Co., Ltd. | DZE | Class II | 2015-11-12 |
| K153060 | Digital Dental Intra Oral Sensor, EzSensor Classic, EzSensor HD, HDI-P, HDI-S | Rayence Co., Ltd. | MUH | Class II | 2015-11-10 |
| K143142 | JDENTALCARE Implant System | Jdentalcare Srl | DZE | Class II | 2015-11-06 |
| K151209 | InterOss | Sigmagraft, Inc. | NPM | Class II | 2015-11-06 |
| K151928 | PUR Dental Implant System | Sterngold Dental, LLC | DZE | Class II | 2015-11-06 |
| K151432 | NaturalLine Abutment | Ot Medical GmbH | NHA | Class II | 2015-11-05 |
| K151619 | Prime&Bond Elect Universal Dental Adhesive | Dentsply International, Inc. | KLE | Class II | 2015-10-30 |
| K151875 | Pavati Zirconia | Ccri, Inc. | EIH | Class II | 2015-10-29 |
| K151894 | IPS Ivocolor | Ivoclar Vivadent, AG | EIH | Class II | 2015-10-29 |
| K152159 | Oravan Herbst | Oravanosa, LLC | LRK | Class II | 2015-10-29 |
| K151723 | Rainbow Trans | Genoss | EIH | Class II | 2015-10-28 |
| K151535 | Cavex Cream Alginate | Cavex Holland BV | ELW | Class II | 2015-10-28 |
| K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | NHA | Class II | 2015-10-23 |
| K150141 | Orthodontics Bracket | Speed Dental Co., Ltd. | NJM | Class II | 2015-10-23 |
| K152180 | PEAK | Neosil Co., Ltd. | ELW | Class II | 2015-10-22 |
| K152066 | Luminesse Anterior Zirconia AT | Talladium, Inc. | EIH | Class II | 2015-10-21 |
| K151646 | ProTech Plus | Protech Professional Products, Inc. | EBI | Class II | 2015-10-21 |
| K151956 | Admira Fusion x-tra | Voco GmbH | EBF | Class II | 2015-10-20 |
| K151844 | Rainbow Shade | Genoss | EIH | Class II | 2015-10-16 |
| K151541 | G-Fix | GC America, Inc. | EBF | Class II | 2015-10-09 |
| K143499 | eCligner | Eclear International Co., Ltd. | NXC | Class II | 2015-10-09 |
| K151169 | OsteoReady ZircoSeal Abutments | Osteoready, LLC | NHA | Class II | 2015-10-08 |
| K150669 | Neoss TiBase, Neoss CoCr Abutments (Mono and Multi) | Neoss, Ltd. | NHA | Class II | 2015-10-08 |
| K150222 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | PLV | Class II | 2015-10-08 |
| K151490 | PRETTAU ANTERIOR T0 | Zirkonzahn GmbH | EIH | Class II | 2015-10-08 |
| K151375 | Inclusive Titanium Abutments compatible with: Hiossen HG Implant System | Prismatik Dentalcraft, Inc. | NHA | Class II | 2015-10-07 |
| K151599 | iSy Implant System | Altatec GmbH | DZE | Class II | 2015-10-02 |
| K143515 | Inclusive® Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants | Prismatik Dentalcraft, Inc. | NHA | Class II | 2015-10-01 |
| K151564 | Telio CAD Abutment Solutions | Ivoclar Vivadent, AG | NHA | Class II | 2015-09-21 |
| K152383 | Ceramill Zolid FX | Emergo Europe Consulting | EIH | Class II | 2015-09-21 |
| K151514 | Prestige | Danville Materials, LLC | EBF | Class II | 2015-09-21 |
| K151262 | Hyflex Heavy, Hyflex Mono, Hyflex Light | Osstem Implant Co., Ltd. | ELW | Class II | 2015-09-21 |
| K151195 | OsteoMed IMF Screw | Osteomed | DZL | Class II | 2015-09-21 |
| K142557 | Anker Dental Implant System - SB-III, ST and AT series | Alliance Global Technology Co., Ltd. | DZE | Class II | 2015-09-21 |
| K150392 | PROPEL device | Propel Orthodontics, LLC | DZJ | Class II | 2015-09-18 |
| K143696 | Spirit | Pelton & Crane | EIA | Class I | 2015-09-18 |
| K151518 | BRUSH&BOND PLUS | Parkell, Inc. | KLE | Class II | 2015-09-18 |
| K151302 | Clinpro Varnish | 3M Company | LBH | Class II | 2015-09-18 |
| K150965 | LeForte System II | Jeil Medical Corporation | JEY | Class II | 2015-09-17 |
| K150899 | Straumann CARES Titanium Alloy (TAN) Abutment | Straumann USA, LLC | NHA | Class II | 2015-09-16 |
| K143051 | ArgenIS Titanium Abutments | The Argen Corporation | NHA | Class II | 2015-09-16 |
| K151630 | G.o.c.c.l.e.s. | Pierrel Pharma S.R.L. | NXV | Class II | 2015-09-15 |
| K141177 | VITALA PORCINE DERIVED COLLAGEN MEMBRANE | Osteogenics Biomedical, Inc. (Formerly Obi Biologi | NPL | Class II | 2015-09-15 |
| K151144 | SuPro 100 | 3M Deutschland GmbH | EBG | Class II | 2015-09-14 |
| K151324 | Straumann Variobase for CEREC | Straumann USA, LLC | NHA | Class II | 2015-09-11 |
| K151526 | Zone, ZoneFree, Zone A1 | Sybron Dental Specialties | EMA | Class II | 2015-09-10 |
| K151248 | PIEZOSURGERY WHITE | Mectron S.P.A. | DZI | Class II | 2015-09-04 |
| K151171 | TRAUS SUS10 | Saeshin Precision Co., Ltd. | DZI | Class II | 2015-09-01 |
| K143539 | Dental Implant OKTAGON Bone Level | Hager& Meisinger GmbH | DZE | Class II | 2015-08-31 |
| K151088 | DMRC Bulk Fill | Danville Materials, LLC | EBF | Class II | 2015-08-28 |
| K150572 | Respire Pink Series-Herbst-EF | Respire Medical Holding | LRK | Class II | 2015-08-27 |
| K150040 | Implanova | Dental Evolutions, Inc. | DZE | Class II | 2015-08-27 |
12,679 clearances in the Dental panel. Data: openFDA.