Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 35
- Latest Decision
- 2019-10-02
Clearances · page 18 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K191363 | Neocis Planning Software Application (NPSA) for 3rd Party PCs | Neocis, Inc. | PLV | Class II | 2019-10-02 |
| K190048 | UF(II) Anatomic abutment | Dio Corporation | NHA | Class II | 2019-09-30 |
| K191774 | SmileAlign Orthodontic Aligner System | 3D Global Biotech, Inc. | NXC | Class II | 2019-09-30 |
| K191524 | Visalys Tooth Primer | Kettenbach GmbH & Co. KG | KLE | Class II | 2019-09-29 |
| K190059 | CEREC Guides | Dentsply Sirona | NDP | Class I | 2019-09-27 |
| K182009 | Dia-Proseal | DiaDent Group International | KIF | Class II | 2019-09-26 |
| K183391 | Novidia Universal Bond | Nobio , Ltd. | KLE | Class II | 2019-09-24 |
| K181416 | Sapphire Dorsal Comfort Fit | Crane Dental Laboratory, Inc. | LRK | Class II | 2019-09-17 |
| K182921 | Infinix Universal Composite | Nobio , Ltd. | EBF | Class II | 2019-09-13 |
| K183695 | OrthoAnalysis Software | Inteware Co., Ltd. | PNN | Class II | 2019-09-12 |
| K191605 | Neocis Guidance System (NGS) | Neocis, Inc. | PLV | Class II | 2019-09-11 |
| K191619 | TurboTemp EZ | Zest Anchors, LLC | EBG | Class II | 2019-09-11 |
| K181986 | Klinly Ultrasonic Tongue Cleaner | Kea Products, Ltd. | QIA | Class I | 2019-09-06 |
| K192119 | 3M Clarity Aligners | 3M Company | NXC | Class II | 2019-09-05 |
| K190930 | SmarTemp X1 | Parkell, Inc. | EBG | Class II | 2019-09-05 |
| K190758 | Opus Bulk Fill APS, Opus Bulk Fill Flow APS | Dentscare Ltda | EBF | Class II | 2019-09-04 |
| K183347 | K3 | Osstem Implant Co., Ltd. | EIA | Class I | 2019-09-04 |
| K191034 | VPS Impression Material | Hygedent, Inc. | ELW | Class II | 2019-09-04 |
| K192042 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen, Geistlich Perio-System Combi-Pack, Geistlich Mucograft and Geistlich Mucograft Seal | Geistlich Pharma AG | NPL | Class II | 2019-08-29 |
| K182219 | SGS Dental Implants System | Sgs International, Ltd. | DZE | Class II | 2019-08-29 |
| K190236 | O2Vent Optima | Oventus Manufacturing Pty, Ltd. | LRK | Class II | 2019-08-29 |
| K191382 | IPS e.max CAD Abutment Solutions- extra systems | Ivoclar Vivadent, AG | NHA | Class II | 2019-08-26 |
| K191427 | Halley resin system | Dentsply Sirona | EBI | Class II | 2019-08-26 |
| K191990 | OSW Aligner System | Osw Manufacturing, LLC | NXC | Class II | 2019-08-23 |
| K181888 | Osstell Beacon | Osstell AB | EKX | Class I | 2019-08-22 |
| K191623 | ScanX Touch/ScanX Duo Touch | Air Techniques, Inc. | MUH | Class II | 2019-08-21 |
| K191079 | Piezon Built-in Kit, Piezon Built-in Kit LED | E.M.S Electro Medical Systems S.A | ELC | Class II | 2019-08-16 |
| K190849 | IS-III active System_S-narrow Type | Neobiotech Co., Ltd. | DZE | Class II | 2019-08-14 |
| K190491 | Blue Sky Bio Zygomatic Implant System | Blue Sky Bio, LLC | NHA | Class II | 2019-08-12 |
| K182881 | Bone Screw, Bone Tack | Osstem Implant Co., Ltd. | DZL | Class II | 2019-08-09 |
| K191222 | Inclusive Titanium Abutments compatible with: Dentsply Implants Astra Tech Implant System EV | Prismatik Dentalcraft, Inc. | NHA | Class II | 2019-08-05 |
| K190569 | Shaders ZR | Digital Age Dental Lab | EIH | Class II | 2019-07-29 |
| K190339 | Helioseal F Plus | Ivoclar Vivadent, AG | EBC | Class II | 2019-07-29 |
| K180845 | Maxima Electric System | Handpiece Headquarters - Hpr, Inc. | EBW | Class I | 2019-07-25 |
| K183121 | Qraypen | AIOBIO Co., Ltd. | EIA | Class I | 2019-07-18 |
| K182908 | Ziacom Dental Implant Systems | Ziacom Medical, S.L. | DZE | Class II | 2019-07-18 |
| K183270 | Silent Nite sl | Prismatik Dentalcraft, Inc. | LRK | Class II | 2019-07-17 |
| K182455 | A.B. DENTAL DEVICES Dental Implants System | A.B. Dental Device , Ltd. | NHA | Class II | 2019-07-15 |
| K182091 | Osstem Abutment System | Osstem Implant Co., Ltd. | NHA | Class II | 2019-07-12 |
| K182714 | Novidia Bulk Fill Flow Composite | Nobio , Ltd. | EBF | Class II | 2019-07-12 |
| K190718 | Zygomatic Implants | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | DZE | Class II | 2019-07-11 |
| K182854 | GC FujiCEM 2 (Improved) | GC America, Inc. | EMA | Class II | 2019-07-11 |
| K183079 | Conometric Abutments | Dentsply Sirona, Inc. | NHA | Class II | 2019-07-10 |
| K180365 | PRAMA White Implant Systems | Sweden & Martina S.P.A. | DZE | Class II | 2019-07-08 |
| K182615 | Surgikor Dental Implant System | Surgikor, LLC | DZE | Class II | 2019-07-08 |
| K180968 | AlphaDent Implants Dental Implants System | Alphadent Implants, Ltd. | DZE | Class II | 2019-07-03 |
| K182780 | XP Composite | S&C Polymer Silicon- Und Composite Spezialitaeten GmbH | EBF | Class II | 2019-07-03 |
| K182580 | Novidia Flowable Composite | Nobio , Ltd. | EBF | Class II | 2019-07-03 |
| K190272 | Bluephase PowerCure | Ivoclar Vivadent, AG | EBZ | Class II | 2019-07-03 |
| K190724 | MD-Temp Plus | Meta Biomed Co., Ltd. | EBG | Class II | 2019-07-03 |
| K183138 | Certain BellaTek Express and BellaTek Flex Abutments | Biomet 3i | NHA | Class II | 2019-07-02 |
| K190687 | Twilite Appliance | Stephen J Harkins, Dds, PC | LRK | Class II | 2019-07-02 |
| K190696 | Stryker Surgeon iD Mandible Recon Plate | Stryker | JEY | Class II | 2019-06-28 |
| K190654 | Straumann CI RD Ceramic Healing Caps | Institut Straumann AG | NHA | Class II | 2019-06-28 |
| K190583 | DynaFlex | Dyna Flex | NXC | Class II | 2019-06-27 |
| K190097 | Straumann CARES Screw-Retained Bridges and Bars | Institut Straumann AG | NHA | Class II | 2019-06-26 |
| K190299 | Elos Accurate® Customized Abutment | Elos Medtech Pinol A/S | NHA | Class II | 2019-06-26 |
| K190597 | BRILLIANT EverGlow Flow | Coltene/Whaledent AG | EBF | Class II | 2019-06-21 |
| K183580 | Panthera Dental Milled Bars | Panthera Dental, Inc. | NHA | Class II | 2019-06-20 |
| K182658 | Bioliner | Five Star Orthodontic Lab & Supply | NXC | Class II | 2019-06-19 |
| K190662 | MRI Compatibility for Existing Straumann Dental Implant Systems | Straumann USA, LLC | DZE | Class II | 2019-06-17 |
| K181965 | Restore Toothpaste | Dr. Collins, Inc. | LBH | Class II | 2019-06-13 |
| K190051 | TD Clip | Zephyr Sleep Technologies, Inc. | LRK | Class II | 2019-06-07 |
| K180952 | Ceramic Bracket | Mem Dental Technology Co., Ltd. | NJM | Class II | 2019-06-07 |
| K182145 | tün® ultrasonic tips product family | Engineered Endodontics | ELC | Class II | 2019-06-07 |
| K183229 | Argen Clear Aligner | Argen Corporation | NXC | Class II | 2019-06-07 |
| K190503 | CeraSeal | Meta Biomed Co., Ltd. | KIF | Class II | 2019-06-07 |
| K180671 | MINE | Rht Co., Ltd. | EHD | Class II | 2019-06-05 |
| K182625 | Diapex Plus | DiaDent Group International | KIF | Class II | 2019-06-03 |
| K190510 | GuttaSil | Meta Biomed Co., Ltd. | KIF | Class II | 2019-05-29 |
| K191122 | 3M RelyX Pediatric Resin Modified Glass Ionomer Cement | 3M Espe Dental Products | EMA | Class II | 2019-05-29 |
| K183337 | LuxaCrown, Shade A1, A2, A3, A3.5; LuxaCrown B1, B3, C2, D2 | DMG Chemisch-Pharmazeutische Fabrik GmbH | EBG | Class II | 2019-05-29 |
| K181157 | Conical Plus Implant System | Osseofuse International, Inc. | DZE | Class II | 2019-05-24 |
| K190436 | KATANA Zirconia Block | Kuraray Noritake Dental, Inc. | EIH | Class II | 2019-05-23 |
| K182350 | Dental Ceramic | Baot Biological Technology Co., Ltd. | EIH | Class II | 2019-05-22 |
| K183242 | ET IV SA Dental Implants | Hiossen, Inc. | DZE | Class II | 2019-05-21 |
| K173570 | SD Abutment | Surgident Co., Ltd. | NHA | Class II | 2019-05-17 |
| K183310 | Encore System | Siesta Medical, Inc. | ORY | Class II | 2019-05-09 |
| K190948 | Magic Clear Aligners | Voodoo Manufacturing, Inc. | NXC | Class II | 2019-05-09 |
| K183443 | SomnoDent Avant | Somnomed, Inc. | LRK | Class II | 2019-05-08 |
| K181854 | OssBuilder System | Osstem Implant Co., Ltd. | DZL | Class II | 2019-05-07 |
| K182118 | armor LC | Mavrik Dental Systems, Ltd. | EIE | Class I | 2019-05-03 |
| K182430 | CLEARFIL MAJESTY IC | Kuraray Noritake Dental, Inc. | EBF | Class II | 2019-05-03 |
| K182017 | Compex HD | Addent, Inc. | QGO | Class I | 2019-04-29 |
| K190627 | VALO Grand Corded | Ultradent Products, Inc. | EBZ | Class II | 2019-04-29 |
| K183537 | PANAVIA SA Cement Universal | Kuraray Noritake Dental, Inc. | EMA | Class II | 2019-04-25 |
| K190043 | Halley resin | Dentsply Sirona | EBI | Class II | 2019-04-24 |
| K182778 | LC GLOSSFILL XR | S&C Polymer Silicon- Und Composite Spezialitaeten GmbH | EBF | Class II | 2019-04-22 |
| K180065 | FUSION Plus Curing Light | Dentlight, Inc. | EBZ | Class II | 2019-04-19 |
| K181571 | OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor | Mark Abramson, D.D.S., Inc. | PLC | Class II | 2019-04-19 |
| K181747 | Orthodontic Appliance | Shandong Huge Dental Material Corporation | NXC | Class II | 2019-04-18 |
| K190082 | Straumann BLX Variobase Abutment | Institut Straumann AG | NHA | Class II | 2019-04-17 |
| K182246 | MIST IC | Imagine Milling Technologies, LLC | NHA | Class II | 2019-04-16 |
| K182999 | General Cutting Contra Handpiece | Nakanishi, Inc. | EGS | Class I | 2019-04-16 |
| K190079 | ArgenZ HT+ | The Argen Corporation | EIH | Class II | 2019-04-12 |
| K190453 | VisCalor bulk | Voco GmbH | EBF | Class II | 2019-04-11 |
| K190058 | PureSleep (OTC use) | Sleep Science Partners, Inc. | LRK | Class II | 2019-04-11 |
| K181110 | PROPHYflex 4 | Kaltenbach & Voigt GmbH | EFB | Class I | 2019-04-10 |
| K190040 | Straumann BLX Line Extension - New Abutments | Institut Straumann AG | NHA | Class II | 2019-04-08 |
| K183304 | Prettau, ICE, Z-White zirconia blanks | Zirkonzahn Srl | EIH | Class II | 2019-04-04 |
12,679 clearances in the Dental panel. Data: openFDA.