Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 27
- Latest Decision
- 2021-09-30
Clearances · page 13 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K210523 | Implanova | Dental Evolutions, Inc. | DZE | Class II | 2021-09-30 |
| K210763 | Inman Digital Clear Aligners | Inman Orthodontic Laboratories, Inc. | NXC | Class II | 2021-09-29 |
| K212080 | Imaging Plate Scanner, i-Scan | Guilin Woodpecker Medical Instrument Co., Ltd. | MUH | Class II | 2021-09-27 |
| K212108 | Dynamic TiBase | Talladium España, SL | NHA | Class II | 2021-09-24 |
| K212125 | Nobel Biocare Dental Implant Systems Portfolio - MR Conditional | Nobel Biocare AG | DZE | Class II | 2021-09-24 |
| K202092 | ABC Dental Implant System | Abracadabra Implants , Ltd. | DZE | Class II | 2021-09-23 |
| K212660 | Smylio Invisible Clear Aligners | Smylio, Inc. | NXC | Class II | 2021-09-22 |
| K210045 | ACTIVA PRESTO PACK | Pulpdent Corporation | EBF | Class II | 2021-09-22 |
| K212961 | SMILERS | Biotech Dental Smilers, Sas | NXC | Class II | 2021-09-20 |
| K202790 | Syntec Orthodontic Mini Screw Extended System | Syntec Scientific Corporation | OAT | Class II | 2021-09-17 |
| K212283 | BioRoot Flow 0.5g, BioRoot Flow 2g | Septodont | KIF | Class II | 2021-09-16 |
| K202369 | RXS 1000 | Rolence Enterprise, Inc. | MUH | Class II | 2021-09-15 |
| K203649 | TruAbutment DS, TruBase | Truabutment, Inc. | NHA | Class II | 2021-09-15 |
| K210410 | s-Clean Pre-Milled Abutment Mini | Dentis Co., Ltd. | NHA | Class II | 2021-09-10 |
| K202786 | Dental Low-speed Handpieces and Accessories | Microp Technology (Taiwan), Inc. | EFB | Class I | 2021-09-03 |
| K212103 | StarX-1, StarX-2, StarX PRO-1 and StarX PRO-2 | Fona S.R.L | MUH | Class II | 2021-08-30 |
| K203554 | AnyOne External Implant System | Megagen Implant Co., Ltd. | DZE | Class II | 2021-08-28 |
| K211995 | Sonendo Filling Material 5C | Sonendo, Inc. | KIF | Class II | 2021-08-27 |
| K210373 | Clear Aligners | Shenzhen Yinuo Dental Technology Co.Ltd | NXC | Class II | 2021-08-27 |
| K210610 | PrimeTaper EV Dental Implant | Dentsply Sirona, Inc. | DZE | Class II | 2021-08-27 |
| K202952 | Amber Mill Q Series & Amber Mill Direct Series | Hass Corp. | EIH | Class II | 2021-08-26 |
| K203344 | Premilled Titanium Block System | Innobiosurg Co., Ltd. | NHA | Class II | 2021-08-25 |
| K200657 | SmartGuard Anti-Snoring Device | Smartguard Rx, Inc. | LRK | Class II | 2021-08-23 |
| K211916 | IPS e.max One | Ivoclar Vivadent, AG | EIH | Class II | 2021-08-20 |
| K211551 | Wishbone HA | Wishbone SA | NPM | Class II | 2021-08-20 |
| K210203 | mmRNA appliance | Vivos Therapeutics, Inc. (Formerly Vivos Biotechnologies, I) | LRK | Class II | 2021-08-19 |
| K211584 | Oral Surgery Contra | Nakanishi, Inc. | KMW | Class II | 2021-08-19 |
| K210362 | s-Clean Pre-Milled Abutment | Dentis Co., Ltd. | NHA | Class II | 2021-08-19 |
| K210336 | Neodent Implant System - Zirconia Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | DZE | Class II | 2021-08-13 |
| K212229 | White Endoseal MTA | Maruchi | KIF | Class II | 2021-08-13 |
| K211799 | Biodentine XP 500, Biodentine XP 200 | Septodont | KIF | Class II | 2021-08-10 |
| K210320 | ClearCorrect System | Clearcorrect, LLC | NXC | Class II | 2021-08-06 |
| K200193 | Kisses Plus Implant System | Achimhai Medical Corporation | NHA | Class II | 2021-08-06 |
| K202969 | Biomet Microfixation OmniMax MMF System | Biomet Microfixation | JEY | Class II | 2021-08-05 |
| K203464 | DESS Dental Smart Solutions | Terrats Medical SL | NHA | Class II | 2021-08-04 |
| K203542 | Neodent Implant System - Mini Abutment 60° | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | NHA | Class II | 2021-08-02 |
| K210115 | FiteBac CC OrthoSeal | Largent Health, LLC | DYH | Class II | 2021-07-29 |
| K202825 | BTI Extra-Short Dental Implant System UnicCa | B.T.I. Biotechnology Institute, Sl. | DZE | Class II | 2021-07-29 |
| K211317 | CRUXVIEW | Cruxell Corp. | MUH | Class II | 2021-07-29 |
| K211014 | Portray | Surround Medical Systems | EHD | Class II | 2021-07-28 |
| K211129 | Neocis Guidance System (NGS) with Intraoral Fiducial Array | Neocis, Inc. | PLV | Class II | 2021-07-28 |
| K211225 | MIS Ti-base abutment | Dentsply Sirona | NHA | Class II | 2021-07-28 |
| K210189 | Pac-Dent Denture Base Resin | Pac-Dent, Inc. | EBI | Class II | 2021-07-28 |
| K211489 | Dental Impression Material | Nanchang Dental Bright Technology Co., Ltd. | ELW | Class II | 2021-07-28 |
| K210884 | 1Derful HS, 1Derful HT | 1derful, Inc. | EIH | Class II | 2021-07-27 |
| K210412 | Pac-Dent Ceramic Nanohybrid Resin | Pac-Dent, Inc. | EBF | Class II | 2021-07-26 |
| K210903 | IS Multi Unit Abutment System | Neobiotech Co., Ltd. | NHA | Class II | 2021-07-23 |
| K211688 | DC-Air and Athlos-1 and Athlos-Air | Athlos OY | MUH | Class II | 2021-07-22 |
| K193352 | AbutmentCAD | Exocad GmbH | PNP | Class II | 2021-07-21 |
| K203712 | The Slide | Biotex, Inc. | LQZ | Class II | 2021-07-20 |
| K210349 | TKO Composite Bite Turbo Gel | Reliance Orthodontic Products, Inc. | EBF | Class II | 2021-07-20 |
| K210186 | PacBond One | Pac-Dent, Inc. | KLE | Class II | 2021-07-16 |
| K202846 | TERA HARZ | Graphy, Inc. | EBF | Class II | 2021-07-15 |
| K202918 | OsteoSync Ti Dental Mesh | Sites Medical, LLC | JEY | Class II | 2021-07-14 |
| K211237 | UltraTemp Rez II | Ultradent Products, Inc. | EMA | Class II | 2021-07-13 |
| K210945 | Ultra SEP | Reliance Orthodontic Products, Inc. | KLE | Class II | 2021-07-08 |
| K211052 | Straumann RidgeFit Implants | Institut Straumann AG | DZE | Class II | 2021-07-08 |
| K202579 | TruAbutment DS, TruBase | Truabutment, Inc. | NHA | Class II | 2021-07-08 |
| K193622 | TRIOCLEAR System | Perfection Aligner System Hong Kong Limited | NXC | Class II | 2021-07-06 |
| K203309 | NUVO CF Implant System | JJGC Indústria e Comércio de Materiais Dentários S.A. | DZE | Class II | 2021-07-06 |
| K210097 | Estar-Z | Osstem Implant Co., Ltd. | EIH | Class II | 2021-07-02 |
| K210910 | Snore Bandit | Snorebandit, LLC | LRK | Class II | 2021-07-01 |
| K203672 | MAZIC Claro CAD and MAZIC Claro Press | Vericom Co., Ltd. | EIH | Class II | 2021-07-01 |
| K210904 | Metapaste Plus | Meta Biomed Co., Ltd. | KIF | Class II | 2021-06-30 |
| K201353 | CenterMed Patient Matched Assisted Surgical Planning (ASP) System | Centermed, Inc. | DZJ | Class II | 2021-06-28 |
| K210421 | Diafil & Diafil Capsule | DiaDent Group International | EBF | Class II | 2021-06-28 |
| K203590 | Perfit FS Dental Zirconia Fully Sintered Block | Vatech Acucera, Inc. | EIH | Class II | 2021-06-24 |
| K211259 | Renamel Bulkfill | Cosmedent, Inc. | EBF | Class II | 2021-06-24 |
| K203456 | Straumann CARES M-Series CAD/CAM System | Institut Straumann AG | NHA | Class II | 2021-06-23 |
| K203725 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | DZE | Class II | 2021-06-23 |
| K210161 | AnyOne Onestage Implant System | Megagen Implant Co., Ltd. | DZE | Class II | 2021-06-22 |
| K202855 | Orthodontic Facemask | Ita.O Italian Orthodontic System S.R.L. | DZB | Class II | 2021-06-21 |
| K210855 | Straumann BLX Implant System | Institut Straumann AG | DZE | Class II | 2021-06-21 |
| K193301 | coDiagnostiX | Dental Wings GmbH | DZJ | Class II | 2021-06-21 |
| K210220 | Kontact Dental Implant System | Biotech Dental, Sas | DZE | Class II | 2021-06-18 |
| K210886 | MIS Lance+ Conical Connection Dental Implant System | Dentsply Sirona | DZE | Class II | 2021-06-17 |
| K210694 | Silent Nite Sleep Appliance with the Glidewell Hinge | Prismatik Dentalcraft, Inc. | LRK | Class II | 2021-06-16 |
| K211101 | E-Temp | Envisiontec GmbH | EBG | Class II | 2021-06-14 |
| K210504 | PANAVIA Veneer LC | Kuraray Noritake Dental, Inc. | EMA | Class II | 2021-06-11 |
| K210613 | HIT Clear Aligner | Cdb Corporation | NXC | Class II | 2021-06-04 |
| K210080 | Dentis s-Clean s-Line Mini | Dentis Co., Ltd. | DZE | Class II | 2021-06-04 |
| K201842 | TruBase S | Truabutment, Inc. | NHA | Class II | 2021-06-04 |
| K210652 | 6MS Invisible Aligner | Sms Opco, LLC | NXC | Class II | 2021-06-02 |
| K202832 | Implacil Implant System | Implacil DE Bortoli Material Odontologico Ltda | DZE | Class II | 2021-05-26 |
| K203760 | Tokuyama Universal Bond II | Tokuyama Dental Corporation | KLE | Class II | 2021-05-25 |
| K210977 | E-Dent 1000 | Envisiontec GmbH | EBF | Class II | 2021-05-25 |
| K201192 | Impla-NX (Model: ISE-270M) | Micro-Nx Co., Ltd. | EBW | Class I | 2021-05-21 |
| K203282 | TECHFIT Patient-Specific Maxillofacial System | Industrias Medicas Sampedro S.A.S | JEY | Class II | 2021-05-19 |
| K210540 | Ohlendorf Clear Aligner | Ohlendorf Appliance Laboratory | NXC | Class II | 2021-05-19 |
| K200573 | BoneTrust Mini Implant System | Medical Instinct Deutschland GmbH | DZE | Class II | 2021-05-14 |
| K200555 | Prevest Denpro Dental Cements (Micron Bioactive, Micron Superior, Micron Superior Capsules, Micron Luting, Micron Dentin Conditioner) | Prevest Denpro Limited | EMA | Class II | 2021-05-13 |
| K203320 | Endo Motor | Guilin Woodpecker Medical Instrument Co., Ltd. | EKX | Class I | 2021-05-10 |
| K210298 | GR-14 Resin System | Pro3Dure Medical GmbH | EBI | Class II | 2021-05-05 |
| K203240 | AccelX Abutments | Integrated Dental Systems, LLC | NHA | Class II | 2021-04-27 |
| K211010 | Illusion Aligners | Laxmi Dental Exports Pvt, Ltd. | NXC | Class II | 2021-04-26 |
| K210347 | VSP System | 3D Systems | DZJ | Class II | 2021-04-26 |
| K210312 | PlutoX Digital Intraoral X-Ray Imaging System | Iray Technology Taicang , Ltd. | MUH | Class II | 2021-04-23 |
| K211190 | 3M Clarity Aligners (3M Clarity Aligners-Force, 3M Clarity Aligners-Flex) | 3M Company, Unitek Orthodontic Products | NXC | Class II | 2021-04-23 |
| K200329 | IDCAM Dental Implants | Implants Diffusion International | DZE | Class II | 2021-04-22 |
| K210134 | Dentis s-Clean s-Line | Dentis Co., Ltd. | DZE | Class II | 2021-04-19 |
12,679 clearances in the Dental panel. Data: openFDA.