Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 31
- Latest Decision
- 2021-04-19
Clearances · page 14 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K203824 | VPS Impression Material | Hygedent, Inc. | ELW | Class II | 2021-04-19 |
| K203701 | Locator Overdenture Implant System | Ivory Super Holdco Inc. / Zest Anchors, LLC | DZE | Class II | 2021-04-15 |
| K202617 | Metapex Plus | Meta Biomed Co., Ltd. | KIF | Class II | 2021-04-14 |
| K202906 | EndoPilot2 | Schlumbohm GmbH & Co. KG | ELC | Class II | 2021-04-13 |
| K201563 | PuRE PMMA Disc | Quest Dental USA Corp. | EBG | Class II | 2021-04-09 |
| K203499 | Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank | Vatech Acucera, Inc. | EIH | Class II | 2021-04-05 |
| K202183 | Porcine Mineral Collagen Composite | Collagen Matrix, Inc. | NPM | Class II | 2021-04-02 |
| K202909 | CreoDent Solidex Customized Abutment | Creodent Prosthetics, Ltd. | NHA | Class II | 2021-04-02 |
| K203641 | E-Denture Pro | Envisiontec GmbH | EBI | Class II | 2021-03-30 |
| K200601 | LumiCare Caries Diagnostic Rinse | GreenMark Biomedical, Inc. | LFC | Class II | 2021-03-29 |
| K201197 | TruAbutment DS, TruBase S | Truabutment, Inc. | NHA | Class II | 2021-03-26 |
| K210333 | DiaPaste | DiaDent Group International | KIF | Class II | 2021-03-25 |
| K202015 | White ENDOSEAL MTA | Maruchi | KIF | Class II | 2021-03-24 |
| K210828 | DIOnavi-Denture02 | Dio Corporation | EBI | Class II | 2021-03-23 |
| K203737 | Spark Clear Aligner System | Ormco Corporation | NXC | Class II | 2021-03-22 |
| K203116 | SensorX | Durr Dental SE | MUH | Class II | 2021-03-19 |
| K210041 | HySil Plus Impression Materials | Osstem Implant Co., Ltd. | ELW | Class II | 2021-03-18 |
| K202773 | s-Clean SQ-SL Implant System Mini | Dentis Co., Ltd. | DZE | Class II | 2021-03-18 |
| K201681 | Straumann Immediate Temporary Abutments | Institut Straumann AG | NHA | Class II | 2021-03-18 |
| K203252 | Multi-unit Abutments for CONELOG | BioHorizons Implant Systems, Inc. | NHA | Class II | 2021-03-16 |
| K203382 | Neodent Implant System-Easy Pack | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | DZE | Class II | 2021-03-15 |
| K201410 | VENUS Bracket, ROSE Bracket | Gni Co., Ltd. | NJM | Class II | 2021-03-12 |
| K192649 | Endo Motor | Foshan Cicada Dental Instrument Co, Ltd. | EKX | Class I | 2021-03-12 |
| K201492 | Non-Sterile Zirconia Block | Bioden Co., Ltd. | EIH | Class II | 2021-03-10 |
| K203606 | Serena Sleep Block Mandibular Advancement (BMA), Serena Sleep Elastic Mandibular Advancement (EMA) | Meris Investment Group | LRK | Class II | 2021-03-10 |
| K203351 | Perfit ZR HT Dental Zirconia blank | Vatech Acucera, Inc. | EIH | Class II | 2021-03-08 |
| K210280 | Geistlich Mucograft®, Geistlich Mucograft® Seal | Geistlich Pharma AG | NPL | Class II | 2021-03-03 |
| K210550 | VALO Grand Corded and Accessory Lenses | Ultradent Products, Inc. | EBZ | Class II | 2021-03-01 |
| K201104 | AsoAligner | Aso International Manila, Inc. | NXC | Class II | 2021-02-26 |
| K173738 | Archworx | Utah Medical Products and Services | NXC | Class II | 2021-02-26 |
| K203477 | Classic | Orthoapnea S.L. | LRK | Class II | 2021-02-25 |
| K201703 | PROXEO Twist Cordless Polishing System PL-40 H | W&H Dentalwerk Buermoos GmbH | EKX | Class I | 2021-02-24 |
| K201915 | GenesisZr 4Y+ (ST1100) Zirconia | United Dental Resources Corporation | EIH | Class II | 2021-02-23 |
| K203442 | Inbrace Orthodontic System | Swift Health Systems, Inc. | PNN | Class II | 2021-02-19 |
| K201860 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | NHA | Class II | 2021-02-19 |
| K203462 | Advanced Dental Appliance | Dasoft Partners | LRK | Class II | 2021-02-19 |
| K210132 | s-Clean SQ-SL Implant System Regular | Dentis Co., Ltd. | DZE | Class II | 2021-02-17 |
| K201799 | CleaniCal | Maruchi | EJK | Class II | 2021-02-12 |
| K193280 | MedCAD® AccuPlate® Patient-Specific Plate | Medcad | JEY | Class II | 2021-02-12 |
| K202281 | EDS Bioceramic Sealer (Bioseal) | Essential Dental Systems | KIF | Class II | 2021-02-12 |
| K192742 | Straumann Variobase C | Institut Straumann AG | NHA | Class II | 2021-02-12 |
| K202651 | NOA Sleep Apnea and Snoring Device | Orthoapnea S.L. | LRK | Class II | 2021-02-12 |
| K203355 | Straumann TLX Novaloc and Cementable Abutments | Institut Straumann AG | NHA | Class II | 2021-02-12 |
| K201222 | Bio-C Repair Ion+ | Angelus Industria DE Produtos Odontologicos S/A | KIF | Class II | 2021-02-11 |
| K192839 | DSP Implant System | D.S.P Industrial Eireli | DZE | Class II | 2021-02-11 |
| K201292 | TRAUS SIP20 | Saeshin Precision Co., Ltd. | EBW | Class I | 2021-02-11 |
| K202942 | Straumann 4 mm Short Implants | Straumann USA, LLC | DZE | Class II | 2021-02-08 |
| K200470 | Shofu Block HC Hard | Shofu Dental Corporation | EBF | Class II | 2021-02-05 |
| DEN200018 | eXciteOSA with remote and eXciteOSA without remote | Signifier Medical Technologies | QNO | Class II | 2021-02-05 |
| K203374 | X-MIND prime (under trade mark Acteon), I-MAX (under trade mark Owandy Radiology) | De Götzen S.R.L. | MUH | Class II | 2021-02-05 |
| K203302 | GentleWave X | Sonendo, Inc. | ELC | Class II | 2021-02-05 |
| K203598 | Omnichroma Flow Bulk | Tokuyama Dental Corporation | EBF | Class II | 2021-02-03 |
| K202282 | Neodent Implant System - Zirconia Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | NHA | Class II | 2021-01-29 |
| K201993 | E-connect S Endo Motor with built-in Apex Locator | Changzhou Sifary Medical Technology Co., Ltd. | EKX | Class I | 2021-01-29 |
| K201608 | GenesisZr UHT700 Zirconia | United Dental Resources Corporation | EIH | Class II | 2021-01-28 |
| K201187 | Cytoplast Titanium-Reinforced PTFE Membranes | Osteogenics Biomedical, Inc. | NPK | Class II | 2021-01-23 |
| K201553 | Simply Iconic Implants | Implant Direct Sybron Manufacturing, LLC | DZE | Class II | 2021-01-22 |
| K202792 | BRIUS Clear Aligners | Brius Technologies, Inc. | NXC | Class II | 2021-01-22 |
| K202629 | Dentsply Sirona Universal Spray Glazes | Dentsply Sirona | EIH | Class II | 2021-01-20 |
| K192913 | R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | KLE | Class II | 2021-01-19 |
| K201719 | Vital Sleep | The Snore Reliever Company, LLC | LRK | Class II | 2021-01-14 |
| K201700 | BEGO Semados® RS/RSX Implant System | Bego Implant Systems GmbH & Co. KG | DZE | Class II | 2021-01-13 |
| K201241 | Striate+ | Orthocell, Ltd. | NPL | Class II | 2021-01-11 |
| K202278 | OBS Anchorage Screw, Biokey Anchorage Screw | Bomei Co, Ltd. | OAT | Class II | 2021-01-08 |
| K203339 | NEOLab Clear Aligners | New England Ortho Lab, Inc. | NXC | Class II | 2021-01-06 |
| K202857 | ClearPath Aligner | Clearpath Orthodontics, Ltd. | NXC | Class II | 2021-01-05 |
| K201800 | Portable Dental X-ray (NR-F350, CS 2400P, CS 2300P, R2 Port-X) | Nanoray Co., Ltd. | EHD | Class II | 2020-12-28 |
| K201491 | Neodent Implant System - Zirconia Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | DZE | Class II | 2020-12-22 |
| K200908 | iSMILE | 3D Diagnostix, Inc. | NXC | Class II | 2020-12-22 |
| K201036 | PlaniMax Orthodontic Software | Choice Biotech, Inc. | PNN | Class II | 2020-12-22 |
| K201707 | Opallis, Opallis Flow | Dentscare Ltda | EBF | Class II | 2020-12-22 |
| K202026 | Blue Sky Bio CAD-CAM Abutments | Blue Sky Bio, LLC | NHA | Class II | 2020-12-18 |
| K190217 | Aidite PMMA | Aidite (Qinhuangdao) Technology Co., Ltd. | EBG | Class II | 2020-12-17 |
| K201919 | Blue Sky Bio TAD | Blue Sky Bio, LLC | OAT | Class II | 2020-12-17 |
| K202095 | CreoDent Solidex Customized Abutment and Screw | Creodent Prosthetics, Ltd. | NHA | Class II | 2020-12-16 |
| K203401 | Neocis Guidance System (NGS) with Patient Splints (EPS) | Neocis, Inc. | PLV | Class II | 2020-12-15 |
| K202673 | X-cera Pre-shaded Zirconia Blanks | Dongguan Xiangtong Co., Ltd. | EIH | Class II | 2020-12-10 |
| K201711 | CARES Screw - Retained Bars and Bridges (SRBB) | Medentika GmbH | NHA | Class II | 2020-12-08 |
| K202264 | Neocis Guidance System (NGS) with Yomi Plan v2.0 | Neocis, Inc. | PLV | Class II | 2020-12-04 |
| K201317 | TTBIO EVOCLEAN Ultrasonic Scaler | Ttbio Corp. | ELC | Class II | 2020-12-04 |
| K202418 | Magic UCLA Abutment System | Innobiosurg Co., Ltd. | NHA | Class II | 2020-12-03 |
| K202452 | NobelProcera Zirconia Implant Bridge | Nobel Biocare AB | NHA | Class II | 2020-12-03 |
| K201940 | Braces on Demand Bracket | Braces on Demand, Inc. | DYW | Class II | 2020-12-03 |
| K201712 | Z5-TL | Z-Systems AG | DZE | Class II | 2020-12-01 |
| K200155 | Bright High Flow | Genoss Co., Ltd. | EBF | Class II | 2020-11-30 |
| K202269 | PRE-MILLED Abutment | Mit Global Co., Ltd. | NHA | Class II | 2020-11-25 |
| K201904 | Monet Curing Laser | CAO Group, Inc. | QNF | Class II | 2020-11-24 |
| K200798 | G-CEM ONE | GC America, Inc. | EMA | Class II | 2020-11-24 |
| K201484 | Somnos Anti-Snoring Mouth Guard | Koncept Innovators, LLC | LRK | Class II | 2020-11-23 |
| K202413 | LC ResinCal PC | S&C Polymer Silicon- Und Composite Spezialitaten GmbH | EJK | Class II | 2020-11-20 |
| K202529 | ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring | Prosomnus Sleep Technologies, Inc. | LRK | Class II | 2020-11-20 |
| K200580 | FotoDent denture | Dreve Dentamid GmbH | EBI | Class II | 2020-11-19 |
| K200992 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | DZE | Class II | 2020-11-17 |
| K202344 | TiUltra Implants and Xeal Abutments | Nobel Biocare AB | DZE | Class II | 2020-11-16 |
| K193193 | Telio CAD Abutment Solutions- extra systems | Ivoclar Vivadent, AG | NHA | Class II | 2020-11-16 |
| K200461 | Freeprint denture | Detax GmbH & Co. KG | EBI | Class II | 2020-11-16 |
| K192612 | Kerecis Gingiva Graft | Kerecis Limited | NPL | Class II | 2020-11-13 |
| K201937 | Ceramir Restore QuikCap | Doxa Dental AB | EMA | Class II | 2020-11-13 |
| K193385 | TP Orthodontics Clear Aligner System | Tp Orthodontics, Inc. | NXC | Class II | 2020-11-12 |
| K183044 | JTK Dental Implant System | Jiangyin Jintech Biotech Co., Ltd. | DZE | Class II | 2020-11-10 |
12,679 clearances in the Dental panel. Data: openFDA.