Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 33
- Latest Decision
- 2017-11-14
Clearances · page 22 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K171769 | Straumann PURE Ceramic Implants | Straumann USA, LLC (On Behalf of Institut Straumann Ag) | DZE | Class II | 2017-11-14 |
| K170102 | Pekkton Ivory | Cendres+Metaux SA | EBF | Class II | 2017-11-13 |
| K161923 | J2A SLA Dental Implant System | Kj Meditech Co., Ltd. | DZE | Class II | 2017-11-09 |
| K171050 | Geistlich Fibro-Gide | Geistlich Pharma AG | NPL | Class II | 2017-11-09 |
| K170773 | Stryker Universal Mesh | Stryker | JEY | Class II | 2017-11-08 |
| K170229 | Dental High-speed Turbine Handpiece | Guangdong Jinme Medical Technology Co., Ltd. | EFB | Class I | 2017-11-08 |
| K163634 | External Hex Implants | Southern Implants (Pty), Ltd. | DZE | Class II | 2017-11-06 |
| K172407 | Duracetal | The Myerson Company Limited | EBI | Class II | 2017-11-02 |
| K170080 | Neodent Implant System - CM Pro PEEK Abutment | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | NHA | Class II | 2017-11-02 |
| K172572 | Stryker Upper-Face AXS screws and Mid-Face AXS screws | Stryker | JEY | Class II | 2017-10-31 |
| K173318 | Rapid HB, Rapid LB, Rapid MB | 3M Deutschland GmbH | ELW | Class II | 2017-10-31 |
| K171008 | Anorganic Bone Mineral with Collagen in Delivery Applicator | Collagen Matrix, Inc. | NPM | Class II | 2017-10-30 |
| K171643 | Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed | Geistlich Pharma AG | NPL | Class II | 2017-10-30 |
| K171142 | Healing Cap Multi-Unit Titanium | Nobel Biocare AB | NHA | Class II | 2017-10-26 |
| K173046 | Cocoon Portable Handheld X-Ray System | Dexcowin Co., Ltd. | MUH | Class II | 2017-10-26 |
| K171831 | Intra-Lock Bone Fixation System | Intra-Lock International, Inc. | DZL | Class II | 2017-10-26 |
| K172352 | TREFOIL System | Nobel Biocare AB | DZE | Class II | 2017-10-20 |
| K170261 | Premium Plus Prophy Air Motor | Premium Plus International Limited | EFB | Class I | 2017-10-19 |
| K172281 | PuRE PMMA Disc | Quest Dental USA Corp. | EBG | Class II | 2017-10-19 |
| K171774 | RPM Reinforced PTFE Mesh | Osteogenics Biomedical, Inc. | NPK | Class II | 2017-10-19 |
| K170834 | CERABIEN ZR | Kuraray Noritake Dental, Inc. | EIH | Class II | 2017-10-17 |
| K170394 | Kisses Mini | Achimhai Medical Corporation | DZE | Class II | 2017-10-06 |
| K170375 | Nobilplast Denture Resin | Cmp Industries, LLC | EBI | Class II | 2017-10-02 |
| K170873 | Medi Galaxy Flow, Medi Classic, Medi Pearl, Medi Jupiter, Medi Opaque Posterior, Medi White Pearl | Swissmeditec GmbH | EBF | Class II | 2017-10-02 |
| K171795 | Thommen Implant System | Thommen Medical AG | DZE | Class II | 2017-09-29 |
| K171728 | MOR 3.0mm and PUR NP 3.2mm Implant Systems, MOR 2.1x18mm and 2.4x18mm | Sterngold Dental, LLC | DZE | Class II | 2017-09-28 |
| K171922 | Anatotemp Anatomic Dental Implant Healing Abutment | Buckeye Medical Technologies, LLC | NHA | Class II | 2017-09-28 |
| K162848 | Straumann CARES Golden Ti/TiN Abutments | Institut Straumann AG | NHA | Class II | 2017-09-22 |
| K170013 | Eztetic BellaTek Encode Healing Abutments | Biomet 3i | NHA | Class II | 2017-09-21 |
| K171876 | Ceramill Zolid HT+ white | Amann Girrbach AG | EIH | Class II | 2017-09-20 |
| K170838 | Medentika CAD/CAM TiBases | Medentika GmbH | NHA | Class II | 2017-09-15 |
| K162482 | A.B. DENTAL DEVICES Dental Implants System | A.B. Dental Device , Ltd. | DZE | Class II | 2017-09-15 |
| K171189 | AIR-FLOW PLUS Prophylaxis powder | E.M.S Electro Medical Systems S.A | EJR | Class I | 2017-09-11 |
| K170275 | Tri Auto ZX2 | J. Morita USA, Inc. | EKX | Class I | 2017-09-11 |
| K170596 | TN-Brush | Genoss Co., Ltd. | ELB | Class II | 2017-09-11 |
| K170822 | Electronic Caries Detector | Ortek Therapeutics, Inc. | NBL | Class II | 2017-09-11 |
| K171330 | Nanova Sealant | Nanova Biomaterials, Inc. | EBC | Class II | 2017-09-08 |
| K171126 | Implantium II | Dentium Co., Ltd. | DZE | Class II | 2017-09-07 |
| K171027 | Dentis Dental Implant System | Dentis Co., Ltd. | DZE | Class II | 2017-09-06 |
| K172106 | SHOFU MZ Primer Plus | Shofu Dental Corporation | KLE | Class II | 2017-08-31 |
| K163402 | NLZ Motor System | Nakanishi, Inc. | EBW | Class I | 2017-08-31 |
| K170031 | Internal Octa Implant System | Ebi, Inc. | DZE | Class II | 2017-08-31 |
| K163385 | Cortex Dental Implant System | Cortex Dental Implants Industries , Ltd. | DZE | Class II | 2017-08-29 |
| K162543 | Reverse Pull Adjustable Facemask | Sawbros Industries Pvt., Ltd. | DZB | Class II | 2017-08-28 |
| K170825 | SnoreRx | Apnea Sciences Corporation | LRK | Class II | 2017-08-18 |
| K170384 | Dentium NR Line CAD/CAM Abutments | Dentium Co., Ltd. | NHA | Class II | 2017-08-17 |
| K172426 | Clear Blue Digi LED Curing Light | Promident, LLC | EBZ | Class II | 2017-08-16 |
| K163568 | SHOFU RESIN GLAZE | Shofu Dental Corporation | EBD | Class II | 2017-08-16 |
| K163483 | PANA SPRAY Plus | Nakanishi, Inc. | EFB | Class I | 2017-08-15 |
| K163398 | ATLANTIS suprastructures | Dentsply Sirona | NHA | Class II | 2017-08-14 |
| K171200 | Grandio blocs | Voco GmbH | EBF | Class II | 2017-08-10 |
| K170529 | Delight, Delight ortho, B&Lite S | Dentall Co., Ltd. | EBZ | Class II | 2017-08-08 |
| K170588 | DESS Dental Smart Solutions | Terrats Medical SL | NHA | Class II | 2017-08-08 |
| K170272 | TruMatch CMF Titanium 3D Printed Implant System | Materialise NV | JEY | Class II | 2017-08-08 |
| K171147 | REVEAL Bulk | Bisco, Inc. | EBF | Class II | 2017-08-04 |
| K160850 | Nucleoss Tpure Implant System | Sanlilar Tibbi Cihazlar Med. Kim.San.Tic.Ltd.Sti | DZE | Class II | 2017-08-04 |
| K163251 | Life Essence Universal Porcelain System | Blue Sky Bio | EIH | Class II | 2017-08-04 |
| K170894 | Zirconia Dental Ceramics | Chengdu Besmile Biotechnology Co., Ltd. | EIH | Class II | 2017-08-01 |
| K170885 | DD cubeX2 HS | Dental Direkt GmbH | EIH | Class II | 2017-08-01 |
| K170207 | Obturys | Itena Clinical | KIF | Class II | 2017-07-31 |
| K162816 | SML-OSA2 Appliances | Selane Products, Inc. | LQZ | Class II | 2017-07-27 |
| K162867 | MagDen Dental Implant System | Shinhung Mst Co., Ltd. | DZE | Class II | 2017-07-26 |
| K170812 | HygePLUS Alginate Impression Material | Hygedent, Inc. | ELW | Class II | 2017-07-26 |
| K162633 | Custom Bars | Implant Direct Sybron Manufacturing, LLC | NHA | Class II | 2017-07-24 |
| K171364 | MP LeFort I Plates | Stryker | JEY | Class II | 2017-07-24 |
| K171844 | Inspire ICE aka Inspire ICE Clear Brackets | Ormco Corporation | NJM | Class II | 2017-07-18 |
| K163714 | OSSIX BONE | Datum Dental, Ltd. | NPM | Class II | 2017-07-18 |
| K162856 | Bonart Dental Handpieces (ART), Disposable Prophy Angle (PROFORMANCE) | Bonart Co., Ltd. | EGS | Class I | 2017-07-18 |
| K170100 | CreoDent Solidex Customized Abutment and Screw | Creodent Prosthetics, Ltd. | NHA | Class II | 2017-07-18 |
| K163064 | Demi Ultra | Kerr Corporation | EBZ | Class II | 2017-07-18 |
| K163194 | Neodent Implant System - GM Line | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | DZE | Class II | 2017-07-14 |
| K162853 | Bonafix TWO - Dental Implant System | Bonafix Surgical and Dental Implants | DZE | Class II | 2017-07-14 |
| K170986 | KATANA Zirconia Block | Kuraray Noritake Dental, Inc. | EIH | Class II | 2017-07-13 |
| K171316 | O2Vent W | Oventus Manufacturing Pty, Ltd. | LRK | Class II | 2017-07-11 |
| K170541 | Anorganic Bone Mineral in Delivery Applicator | Collagen Matrix, Inc. | NPM | Class II | 2017-07-07 |
| K162609 | ClearPath Aligner | Clearpath Orthodontics, Ltd. | NXC | Class II | 2017-07-06 |
| K162190 | Rotograph Prime (under trade mark Villa Sistemi Medicali), I-MAX (under trade mark Owandy Radiology) | Villa Sistemi Medicali S.P.A. | MUH | Class II | 2017-07-06 |
| K170549 | TOKUYAMA CUREGRACE | Tokuyama Dental Corporation | EBI | Class II | 2017-07-05 |
| K162572 | NextDent Denture, E-Denture | Vertex-Dental B.V. | EBI | Class II | 2017-06-30 |
| K170372 | SpiralTech Dental Implant System | Spiraltech Superior Dental Implants, Inc. | DZE | Class II | 2017-06-30 |
| K170896 | Admira Fusion x-base | Voco GmbH | EBF | Class II | 2017-06-29 |
| K162299 | Spiral Shape Dental Implant System | Gp Implants | DZE | Class II | 2017-06-22 |
| K170849 | SIMPLANT Guide | Dentsply Sirona | NDP | Class I | 2017-06-15 |
| K161177 | Axiom PX | Anthogyr Sas | DZE | Class II | 2017-06-15 |
| K163467 | C-Line Orthodontic Ceramic Bracket | Biocetec Co., Ltd. | NJM | Class II | 2017-06-14 |
| K163060 | Deep Conical (DC) Implants and Accessories | Southern Implants (Pty), Ltd. | DZE | Class II | 2017-06-13 |
| K170967 | Intraskan DC Plus | Skanray Technologies Private Limited | EHD | Class II | 2017-06-08 |
| K163580 | ASD Oral Appliances | American Sleep Dentistry | LRK | Class II | 2017-06-08 |
| K170101 | Valiant Curing Light | Inter-Med/Vista Dental Products | EBZ | Class II | 2017-06-08 |
| K170356 | Straumann Variobase Abutments | Institut Straumann AG | NHA | Class II | 2017-06-07 |
| K170354 | Straumann Variobase Abutments | Institut Straumann AG | NHA | Class II | 2017-06-07 |
| K170736 | HySil Impression Materials | Osstem Implant Co., Ltd. | ELW | Class II | 2017-06-07 |
| K170044 | Inclusive Titanium Abutments compatible with: MegaGen AnyRidge Implant System | Prismatik Dentalcraft, Inc. | NHA | Class II | 2017-06-06 |
| K163228 | APVolution System | Aesthetic-Press, LLC | EIH | Class II | 2017-06-05 |
| K163482 | Orthodontic Acrylic 2 | Lang Dental Manufacturing Co., Inc. | EBI | Class II | 2017-05-31 |
| K170093 | AcceleDent Optima | Orthoaccel Technology, Inc. | OYH | Class II | 2017-05-26 |
| K163349 | MIS V3 Conical Connection Dental Implant System | Mis Implants Technologies , Ltd. | DZE | Class II | 2017-05-26 |
| K170692 | Respire Pink Series with DentiTrac | Respire Medical Holding | LRK | Class II | 2017-05-26 |
| K170259 | TruAbutment DS | Truabutment | NHA | Class II | 2017-05-25 |
| K170287 | Dental Implants OKTAGON Bone Level Tapered Design | Hager& Meisinger GmbH | DZE | Class II | 2017-05-24 |
12,679 clearances in the Dental panel. Data: openFDA.