Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 31
- Latest Decision
- 2022-09-09
Clearances · page 11 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K222723 | AMBARINO High-Class | Creamed GmbH & Co. Produktions- Und Handels KG | EBF | Class II | 2022-09-09 |
| K213244 | Accusil Dental Impression Materials (Accusil Light Body Regular and Fast Set, Accusil Heavy Body Regular and Fast Set, Accusil Monophase Regular and Fast Set, Accusil Putty Regular and Fast Set, Accusil Bite Registration) | Prevest Denpro Limited | ELW | Class II | 2022-09-09 |
| K221684 | Osstem Abutment System | Osstem Implant Co., Ltd. | NHA | Class II | 2022-09-08 |
| K213947 | Ultrasonic Endo Activation Device (Model:Actor I pro) | Changzhou Bomedent Medical Technology Co.,Ltd | ELC | Class II | 2022-09-08 |
| K220330 | Soundly Anti Snoring Device | Greystone Ip, Ltd. | LRK | Class II | 2022-09-08 |
| K220251 | Neodent Implant System - GM Narrow Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | DZE | Class II | 2022-09-06 |
| K220579 | Hybrid C70 | Digimed Co., Ltd. | EHD | Class II | 2022-09-01 |
| K221475 | MyClearALIGN Dental Aligner System | Key Dental Technologies, LLC | NXC | Class II | 2022-08-31 |
| K221955 | Brasseler GEM, Brasseler GEM10, Brasseler GEM15, Brasseler GEM20 | Realcloud Imaging Inc. Dba Realcloud Imaging | MUH | Class II | 2022-08-31 |
| K221255 | SimpliShade Bulk Fill, SimpliShade Bulk Fill Flow | Kerr Corporation | EBF | Class II | 2022-08-31 |
| K220618 | SaliPen | Saliwell , Ltd. | QTT | Class II | 2022-08-30 |
| K214118 | Riva Cem Automix | Sdi Limited | EMA | Class II | 2022-08-30 |
| K220640 | Bifix Hybrid Abutment Cement | Voco GmbH | EMA | Class II | 2022-08-23 |
| K222274 | FONA XDC | Fona S.R.L | EHD | Class II | 2022-08-23 |
| K210797 | Bio-MEM Ti Reinforced Membrane | B&Medi Co., Ltd. | NPK | Class II | 2022-08-18 |
| K220329 | G-CAM | Graphenano Dental S.L. | EBF | Class II | 2022-08-16 |
| K213026 | Clear Aligner | Shenzhen Meiming Dentistry Technology Co., Ltd. | NXC | Class II | 2022-08-16 |
| K220680 | Denture Base Polymers | Shandong Huge Dental Material Corporation | EBI | Class II | 2022-08-12 |
| K220835 | Arkligners | Arklign Laboratories | NXC | Class II | 2022-08-12 |
| K220648 | OMF ASP System | Vha Dean | DZJ | Class II | 2022-08-11 |
| K220050 | KLS Martin IPS Distraction | KLS Martin L.P. | MQN | Class II | 2022-08-11 |
| K222414 | TERA HARZ DENTURE | Graphy, Inc. | EBI | Class II | 2022-08-11 |
| K221381 | KDG Abutments | Keystone Dental, Inc. | NHA | Class II | 2022-08-10 |
| K212364 | BLT Dental Implant System | Bio Concept Co., Ltd. | DZE | Class II | 2022-08-10 |
| K222357 | DenMat Glutaraldehyde Desensitizer | Denmat Holding, LLC | KLE | Class II | 2022-08-09 |
| K220077 | IMICRYL Composite, Composite Flow Materials | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | EBF | Class II | 2022-08-09 |
| K213609 | NOVA RESIN dual cure, self adhesive resin cement | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | EMA | Class II | 2022-08-09 |
| K221668 | Dental Impression Material | Chemoment Materials Co.,Ltd | ELW | Class II | 2022-08-08 |
| K213477 | Root ZX3 | J. Morita USA, Inc. | EKZ | Class II | 2022-08-03 |
| K220816 | BruxZir NOW | Prismatik Dentalcraft, Inc. | EIH | Class II | 2022-08-02 |
| K220577 | Dental Handpiece, Model CA160, CA160L, and CA500L | Micro-Nx Co., Ltd. | EGS | Class I | 2022-07-29 |
| K221242 | Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Hunan Vsmile Biotechnology Co., Ltd. | EIH | Class II | 2022-07-29 |
| K220048 | NobelProcera Zirconia N1 Base | Nobel Biocare Services AG | NHA | Class II | 2022-07-29 |
| K211952 | BTI Interna Narrow/Plus Dental Implant System UnicCa | B.T.I. Biotechnology Institute, Sl. | DZE | Class II | 2022-07-21 |
| K210731 | KLS Martin Individual Patient Solutions | KLS-Martin L.P. | JEY | Class II | 2022-07-18 |
| K212509 | OSSIX Breeze | Datum Dental, Ltd. | NPL | Class II | 2022-07-18 |
| K213576 | Tatum Surgical Dental Implant System | Suncoast Dental, Inc. Dba Tatum Surgical | DZE | Class II | 2022-07-15 |
| K221814 | OK Handpiece | Jaintek Co.,Ltd | EFB | Class I | 2022-07-15 |
| K213997 | Kontact Dental Implant System | Biotech Dental, Sas | DZE | Class II | 2022-07-15 |
| K221097 | SmileSeries | Ordont Orthodontic Laboratories, Inc. | NXC | Class II | 2022-07-14 |
| K221429 | KDF Zirconia Disc | Denken-Highdental Co., Ltd. | EIH | Class II | 2022-07-14 |
| K213961 | TruAbutment DS, TruBase | Truabutment, Inc. | NHA | Class II | 2022-07-14 |
| K210354 | SNUCONE Bone Level Implant System | Snucone Co., Ltd. | DZE | Class II | 2022-07-13 |
| K221051 | Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Changsha Honchon Technology Co., Ltd. | EIH | Class II | 2022-07-08 |
| K210228 | KLS Martin IPS Preprosthetic | KLS-Martin L.P. | ELE | Class II | 2022-07-08 |
| K212775 | Adin Short Implants | Adin Dental Implants Systems , Ltd. | DZE | Class II | 2022-07-08 |
| K220771 | Stratasys TrueDent | Stratasys, Ltd. | EBI | Class II | 2022-07-07 |
| K221033 | UniPrime A, UniPrime E, UniPrime E/C | S&C Polymer Silicon- Und Composite Spezialitäten GmbH | KLE | Class II | 2022-07-06 |
| K221019 | Osteon Precision Milled Suprastructure | Implant Solutions Pty Ltd (Aka Osteon Medical) | NHA | Class II | 2022-07-05 |
| K220743 | CediTEC | Voco GmbH | EBI | Class II | 2022-07-05 |
| K221909 | J-Temp | Ultradent Products, Inc. | EBF | Class II | 2022-07-01 |
| K212785 | Blue Sky Bio Multi One Implant System, Blue Sky Bio Long Implant System, Blue Sky Bio PEEK temporary abutments | Blue Sky Bio, LLC | DZE | Class II | 2022-06-30 |
| K221286 | CLAROX | Vsi Co., Ltd. | EHD | Class II | 2022-06-29 |
| K220960 | BruxZir Opaque Coloring Liquid | Prismatik Dentalcraft, Inc. | EIH | Class II | 2022-06-29 |
| K220017 | Coloring Liquid | Dongguan Xiangtong Co., Ltd. | EIH | Class II | 2022-06-29 |
| K221233 | DT-703 | Ecotron Co., Ltd. | EHD | Class II | 2022-06-27 |
| K210947 | Navident | Claronav, Inc. | PLV | Class II | 2022-06-27 |
| K210852 | Noris Medical Dental Implants System - Cortical | Noris Medical , Ltd. | DZE | Class II | 2022-06-24 |
| K212043 | TRAUS ENDO | Saeshin Precision Co., Ltd. | EKX | Class I | 2022-06-24 |
| K221008 | HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) | Shanghai Handy Medical Equipment Co., Ltd. | MUH | Class II | 2022-06-22 |
| K213765 | Glidewell 3DP Denture Base Resin | Prismatik Dentalcraft, Inc. | EBI | Class II | 2022-06-22 |
| K220482 | Sherlock | Open Implants, LLC | NHA | Class II | 2022-06-21 |
| K203791 | Stainless Turbine | Nakanishi, Inc. | EFB | Class I | 2022-06-21 |
| K220878 | Straumann TLX Variobase C | Institut Straumann AG | NHA | Class II | 2022-06-16 |
| K203624 | Custom-made Invisible Aligners | Zhejiang Yinchili Medical Technology Co., Ltd. | NXC | Class II | 2022-06-16 |
| K220440 | Dentis s-Clean Abutment Mini | Dentis Co., Ltd. | NHA | Class II | 2022-06-16 |
| K220804 | Dia-X Bond Universal | DiaDent Group International | KLE | Class II | 2022-06-15 |
| K213088 | ZQuiet Advance | Sleeping Well, LLC | LRK | Class II | 2022-06-15 |
| K211466 | Yomi Robotic System with YomiPlan Go | Neocis, Inc. | PLV | Class II | 2022-06-14 |
| K221695 | 3M Filtek Supreme Flowable Restorative | 3M Company Espe Dental Products | EBF | Class II | 2022-06-13 |
| K210804 | Adhese Universal DC, Cention Primer | Ivoclar Vivadent, AG | KLE | Class II | 2022-06-07 |
| K220612 | PrimeLOC Attachment System | Innovative Product Brands, Inc. | NHA | Class II | 2022-06-06 |
| K220751 | Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA | Institut Straumann AG | NHA | Class II | 2022-06-02 |
| K213201 | DeltaFil, DeltaFil Conditioner | DMG Chemisch-Pharmazeutische Fabrik GmbH | EMA | Class II | 2022-06-01 |
| K214096 | Respire Clear | Respire Medical, LLC | LRK | Class II | 2022-05-31 |
| K212680 | LuxCreo Clear Aligner System | LuxCreo, Inc. | NXC | Class II | 2022-05-31 |
| K202920 | OptiComp | Pac-Dent, Inc. | EBF | Class II | 2022-05-25 |
| K220200 | Paltop Conical Implant System | Paltop Advanced Dental Solutions, Ltd. | DZE | Class II | 2022-05-25 |
| K212563 | CalApex Calplus, Cerafill RCS, Endoseal, Nanoseal S, Zical Ultra Paste, Zical Ultra Powder/Liquid | Prevest Denpro Limited | KIF | Class II | 2022-05-23 |
| K212803 | DailyMate Orthodontic Aligner System | 3D Global Biotech, Inc. | NXC | Class II | 2022-05-23 |
| K220423 | PAPAYA & PAPAYA Plus | Genoray Co., Ltd. | MUH | Class II | 2022-05-19 |
| K211396 | Neoss Individual Prosthetics | Neoss, Ltd. | NHA | Class II | 2022-05-17 |
| K212475 | Prevest Denpro Cavity Liners (Apacal ART, Cal LC, Calcigel, CalUltra) | Prevest Denpro Limited | EJK | Class II | 2022-05-13 |
| K213022 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy POWER, handy POWER LED, implantor LED | Cefla S.C. | EBW | Class I | 2022-05-09 |
| K220689 | Vatech Clismile | Rayence Co., Ltd. | NJM | Class II | 2022-05-06 |
| K213482 | TIA Tip, Cariosity, Transillumination Accessory Tip | D4D Technologies, LLC | NTK | Class II | 2022-04-29 |
| K202691 | Ortholock Anchorage Devices | Craniofacial Technologies, Inc. | OAT | Class II | 2022-04-28 |
| K220574 | HYBRID S70 | Digimed Co., Ltd. | EHD | Class II | 2022-04-22 |
| K220605 | Venus Bulk Flow ONE | Kulzer, LLC | EBF | Class II | 2022-04-21 |
| K220252 | High Retention Attachment System | Zest Anchors, LLC | NHA | Class II | 2022-04-14 |
| K220556 | OpenSensorX Series | Dentimax, Inc. | MUH | Class II | 2022-04-13 |
| K211090 | ZENEX Implant System | Izenimplant Co., Ltd. | DZE | Class II | 2022-04-13 |
| K213063 | TLX SRAs and TLX Gold Abutments | Institut Straumann AG | NHA | Class II | 2022-04-08 |
| K220287 | Invisalign System | Align Technology, Inc. | NXC | Class II | 2022-04-07 |
| K213506 | NB 1 SA Implant System | Arum Dentistry Co., Ltd. | DZE | Class II | 2022-04-06 |
| K212463 | Geistlich Bio-Gide, Geistlich Bio-Gide Shape, Geistlich Bio-Gide Compressed, Geistlich Bio-Gide Perio, Geistlich Combi-Kit Collagen and Geistlich Perio-System Combi Pack | Geistlich Pharma AG | NPL | Class II | 2022-04-05 |
| K213282 | ERI Handheld Dental X-ray System (Model AG100) | Energy Resources International Co., Ltd. Hsinchu Branch | EHD | Class II | 2022-04-04 |
| K220022 | TRATE Dental Implant System | Trate AG | DZE | Class II | 2022-04-04 |
| K213432 | MIS Angulated multi-unit abutments | Dentsply Sirona | NHA | Class II | 2022-04-01 |
| K213147 | CERABIEN MiLai | Kuraray Noritake Dental, Inc. | EIH | Class II | 2022-03-28 |
12,679 clearances in the Dental panel. Data: openFDA.