Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 30
- Latest Decision
- 2023-01-12
Clearances · page 10 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K222830 | Rainbow 360 | Kerr Corporation | KLE | Class II | 2023-01-12 |
| K222976 | MU System | Dentis Co., Ltd. | NHA | Class II | 2023-01-12 |
| K191111 | DD Solid Connect® CAD/CAM Abutments | Dental Direkt GmbH | NHA | Class II | 2023-01-11 |
| K211812 | BLUEDIAMOND IMPLANT, Abutment Screw | Megagen Implant Co., Ltd. | DZE | Class II | 2023-01-06 |
| K222872 | DNA Appliance | Vivos Therapeutics, Inc. | LRK | Class II | 2022-12-30 |
| K213260 | CMFlexTM | Dimension Inx Corp. | LYC | Class II | 2022-12-30 |
| K222984 | BioClean Implant Restorative System | Bioclean Dental, LLC | NHA | Class II | 2022-12-29 |
| K223142 | Coltolux Comfort LED Curing Light | Dent4you AG | EBZ | Class II | 2022-12-22 |
| K222894 | Invisalign System, Pre-Formed Attachment System | Align Technology, Inc. | NXC | Class II | 2022-12-22 |
| K202965 | CURA-Temp | Mgnewton , Ltd. | EBG | Class II | 2022-12-21 |
| K213677 | Bonafix 2 Plus | Zentek Medical, LLC | DZE | Class II | 2022-12-20 |
| K222308 | Al Smile Aligner | Nanjing Jiahe Dental Technology Co., Ltd. | NXC | Class II | 2022-12-20 |
| K220517 | IBS System | Innobiosurg Co., Ltd. | DZE | Class II | 2022-12-20 |
| K214076 | EsCem | Spident Co., Ltd. | EMA | Class II | 2022-12-19 |
| K221453 | S.I.N. Dental Implant System | S.I.N. Sistema DE Implante Nacional S.A. | DZE | Class II | 2022-12-15 |
| K214086 | Bright Impress-Light, Bright Impress-Medium, Bright Impress-Heavy, Bright Impress-Bite, Bright Impress-Putty | Genoss Co., Ltd. | ELW | Class II | 2022-12-15 |
| K220873 | Perceptive electric dental motor and control unit | Lares Research | EIA | Class I | 2022-12-15 |
| K221910 | QRS Dental Implants System | Qrs Medical , Ltd. | DZE | Class II | 2022-12-14 |
| K220079 | Magicore Narrow System | Innobiosurg Co., Ltd. | DZE | Class II | 2022-12-14 |
| K213722 | ICE Ceramics, ICE Stains, Fresco | Zirkonzahn Srl | EIH | Class II | 2022-12-14 |
| K222623 | Digital Crown | Sprintray, Inc. | EBF | Class II | 2022-12-14 |
| K202674 | Medidenta High Speed Handpieces | Pac-Dent, Inc. | EFB | Class I | 2022-12-12 |
| K222650 | Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate | Stryker Craniomaxillofacial (Cmf) | JEY | Class II | 2022-12-09 |
| K220826 | LED Curing Light | Foshan Coxo Medical Instrument Co., Ltd. | EBZ | Class II | 2022-12-08 |
| K222750 | Yomi Robotic System | Neocis, Inc. | QRY | Class II | 2022-12-08 |
| K222626 | Dental Zirconia Ceramic | Aidite (Qinhuangdao) Technology Co., Ltd. | EIH | Class II | 2022-12-06 |
| K223632 | Premier's MultiMatch Universal Chameleon Restorative Composite | Premier Dental Products Company | EBF | Class II | 2022-12-06 |
| K220688 | SilentZPro 2.0 | Shinrin-Yoku Traders, LLC | LRK | Class II | 2022-12-02 |
| K220390 | CreoDent Solidex Customized Abutment and Screw | Creodent Prosthetics, Ltd. | NHA | Class II | 2022-12-02 |
| K222368 | MIST IC | Imagine Milling Technologies, LLC | NHA | Class II | 2022-12-01 |
| K222044 | Elos Accurate Customized Abutment | Elos Medtech Pinol A/S | NHA | Class II | 2022-11-30 |
| K222918 | DentCare Aligners | Dentcare Dental Lab Pvt , Ltd. | NXC | Class II | 2022-11-25 |
| K222569 | Ai Ray Dental X-Ray Device | Guilin Woodpecker Medical Instrument Co., Ltd. | EHD | Class II | 2022-11-23 |
| K221152 | CuringPen Dental Curing Light | Changzhou Sifary Medical Technology Co., Ltd. | EBZ | Class II | 2022-11-23 |
| K222992 | iRoot BP Root Repair Material BioAggregate Paste;iRoot FS Fast Set Root Repair Material ;iRoot BP Plus Root Repair Material | Innovative Bioceramix, Inc. | KIF | Class II | 2022-11-22 |
| K221811 | Vista BC Sealer | Inter-Med, Inc. | KIF | Class II | 2022-11-21 |
| K211358 | Implanter incl. Accessories | Guilin Woodpecker Medical Instrument Co., Ltd. | EBW | Class I | 2022-11-21 |
| K212910 | Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece | Shenzhen Carejoy Technology Co., Ltd. | EFB | Class I | 2022-11-17 |
| K222518 | FX Contra | Nakanishi, Inc. | EGS | Class I | 2022-11-17 |
| K220042 | Dentca Base Premium, Dentca Base Hi-Impact | Dentca, Inc. | EBI | Class II | 2022-11-17 |
| K221094 | OmniTaper EV Dental Implants, DS Implants abutments with EV connection | Dentsply Sirona | DZE | Class II | 2022-11-16 |
| K220841 | PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS) | Dentsply Sirona | DZE | Class II | 2022-11-16 |
| K222520 | Zirconia Block | Yilink (Tianjin) Biotechnology Co., Ltd. | EIH | Class II | 2022-11-14 |
| K222475 | SNOR LOCK | Solbaro Co., Ltd. | LRK | Class II | 2022-11-10 |
| K220562 | TiGEN Abutment, ZrGEN Abutment and Scan Healing Abutment | Megagen Implant Co., Ltd. | NHA | Class II | 2022-11-10 |
| K220360 | Tandry CMF Plate System | Microware Precision Co., Ltd. | JEY | Class II | 2022-11-10 |
| K221678 | SprintRay High Impact Denture Base | Sprintray, Inc. | EBI | Class II | 2022-11-10 |
| K222497 | Zaga Zygomatic System | Southern Implants (Pty), Ltd. | DZE | Class II | 2022-11-09 |
| K221855 | Universal CMF System | Stryker Leibinger GmbH & Co KG | JEY | Class II | 2022-11-09 |
| K220874 | Smooth Drive contra angle and straight handpieces | Lares Research | EGS | Class I | 2022-11-07 |
| K222741 | DENU Light Body(Regular, Fast), DENU Heavy Body(Regular, Fast), DENU Putty Set(Regular, Fast) | Hdi, Inc. | ELW | Class II | 2022-11-07 |
| K220346 | Lotus Prophy Angle | Ajk Engineering, Inc. | EGS | Class I | 2022-11-07 |
| K222049 | Yomi Robotic System | Neocis, Inc. | QRY | Class II | 2022-11-04 |
| K223355 | Tera Harz Clear | Graphy, Inc. | NXC | Class II | 2022-11-03 |
| K222583 | Stela Capsule System | Sdi Limited | EBF | Class II | 2022-10-28 |
| K222581 | Stela Automix System | Sdi Limited | EBF | Class II | 2022-10-28 |
| K222231 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | DZE | Class II | 2022-10-27 |
| K222288 | DESS Dental Smart Solutions | Terrats Medical SL | NHA | Class II | 2022-10-27 |
| K221322 | CUSTMBITE Snoring System | Dental Choice Holdings, LLC | LRK | Class II | 2022-10-27 |
| K223058 | EzRay Air 2 Wall (Model: VEX-S350W) | VATECH Co., Ltd. | EHD | Class II | 2022-10-26 |
| K222269 | DESS Dental Smart Solutions | Terrats Medical SL | NHA | Class II | 2022-10-26 |
| K220823 | Preat Abutments | Preat Corporation | NHA | Class II | 2022-10-26 |
| K222127 | Soft Palate Elevator | The Tmj Clinic PC | LRK | Class II | 2022-10-24 |
| K222215 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | NHA | Class II | 2022-10-21 |
| K213106 | BTI Interna Dental Implant System UnicCa - Prosthetic Components | B.T.I. Biotechnology Institute, Sl. | NHA | Class II | 2022-10-20 |
| K213742 | Infinity Pro, Logic, Quality, Sprint | Olsen Indústria E Comércio S.A. | EIA | Class I | 2022-10-19 |
| K211409 | Proximerge 2 Dental Implant System | Quadric Biomed, LLC | DZE | Class II | 2022-10-19 |
| K214054 | TP Orthodontics Light-Cure Adhesive System, TP Orthodontics Pre-Applied Adhesive, TP Orthodontics Etchant208520 | Tp Orthodontics, Inc. | DYH | Class II | 2022-10-14 |
| DEN210027 | The Cooral System | Braincool AB | QUA | Class II | 2022-10-14 |
| K211427 | CREOKORREKT Aligners | Creodent Prosthetics, Ltd. | NXC | Class II | 2022-10-13 |
| K212702 | IM/ST Fixture System | Guilin Fiteeth Medical Instrument Co., Ltd. | DZE | Class II | 2022-10-13 |
| K211872 | PiezoImplant System | Rex Implants, Inc. | NRQ | Class II | 2022-10-12 |
| K221510 | TrusFIL-Flow Flowable Composite Restorative | Rizhao Huge Biomaterials Company, Ltd. | EBF | Class II | 2022-10-12 |
| K222435 | Renamel® Microhybrid ;Renamel® Flowable Microhybrid | Cosmedent, Inc. | EBF | Class II | 2022-10-11 |
| K202163 | Mico One Orthodontic Screw | Ze Fang Technology Co., Ltd. | OAT | Class II | 2022-10-07 |
| K222418 | Nuvola | Gruppo Europeo Ortodonzia Srl | NXC | Class II | 2022-10-07 |
| K221889 | ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring | Prosomnus Sleep Technologies | LRK | Class II | 2022-10-06 |
| K222686 | Perfit FS Dental Zirconia Fully Sintered Block | Vatech Acucera, Inc. | EIH | Class II | 2022-10-06 |
| K220140 | ClearCorrect System | Clearcorrect, LLC | NXC | Class II | 2022-10-05 |
| K213904 | Kerecis Oral | Kerecis | NPL | Class II | 2022-09-30 |
| K220366 | EmbedMed | 3D Lifeprints UK , Ltd. | DZJ | Class II | 2022-09-30 |
| K221548 | Dental Air Polishing Handpiece | Guilin Woodpecker Medical Instrument Co., Ltd. | EFB | Class I | 2022-09-28 |
| K220831 | Dental Implantation Systems, Dental Electrical Motors | Foshan Coxo Medical Instrument Co., Ltd. | EBW | Class I | 2022-09-27 |
| K202144 | A.B. Dental Devices Dental Implants System | A.B. Dental Device , Ltd. | NHA | Class II | 2022-09-23 |
| K222877 | FREEPRINT crown | Detax GmbH | EBF | Class II | 2022-09-23 |
| K213339 | DENU Composite Resin, DENU Flow Resin | Hdi, Inc. | EBF | Class II | 2022-09-23 |
| K220369 | Esthetic Colorant | Kuraray Noritake Dental, Inc. | EIH | Class II | 2022-09-23 |
| K222253 | GlasIonomer FX ULTRA | Shofu Dental Corporation | EMA | Class II | 2022-09-22 |
| K210475 | EQ-M | Meta Systems Co., Ltd. | EKX | Class I | 2022-09-21 |
| K220236 | V-Print dentbase | Voco GmbH | EBI | Class II | 2022-09-21 |
| K213897 | Pro M Class | Saeyang Microtech Co., Ltd. | EKX | Class I | 2022-09-19 |
| K222131 | NB 1 SA Implant System | Arum Dentistry Co., Ltd. | DZE | Class II | 2022-09-19 |
| K221249 | L1P-1F (TRIOS 5) | 3Shape TRIOS A/S | NBL | Class II | 2022-09-16 |
| K220339 | Esthetic Abutments Nobel Biocare N1 | Nobel Biocare Services AG | NHA | Class II | 2022-09-16 |
| K221194 | LEDEX | Dentmate Technology Co. , Ltd. | EBZ | Class II | 2022-09-16 |
| K221966 | Dynamic TiBase | Talladium Espana, SL | NHA | Class II | 2022-09-15 |
| K220978 | TSX Implants | Biomet 3i, LLC | DZE | Class II | 2022-09-14 |
| K220979 | SprintRay Denture Base | Sprintray, Inc. | EBI | Class II | 2022-09-14 |
| K222764 | LightForce Orthodontic System | Lightforce Orthodontics | NJM | Class II | 2022-09-14 |
| K221450 | Phosphoric Acid Etching Gel | Rizhao Huge Biomaterials Company, Ltd. | KLE | Class II | 2022-09-12 |
12,679 clearances in the Dental panel. Data: openFDA.