Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 29
- Latest Decision
- 2024-12-27
Clearances · page 5 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K241972 | BLUEDIAMOND IMPLANT | Megagen Implant Co., Ltd. | DZE | Class II | 2024-12-27 |
| K233252 | Straumann CARES Visual and Nova Dental CAD | Institut Straumann AG | PNP | Class II | 2024-12-26 |
| K243103 | Denture Base | Riton 3D Technology Co., Ltd. | EBI | Class II | 2024-12-23 |
| K242929 | Fas Aligner System | Xplora 3D Europe S.L | NXC | Class II | 2024-12-20 |
| K242572 | TopCEM-Try in Veneer Try-in Gel | Rizhao Huge Biomaterials Company, Ltd. | EBF | Class II | 2024-12-20 |
| K240435 | Alpha Dent Implants Dental Implants System | Alpha Dent Implants GmbH | DZE | Class II | 2024-12-20 |
| K243911 | HPR Cordless Hygiene Handpiece | Handpiece Headquarters | EKX | Class I | 2024-12-20 |
| K242530 | HF-Etchant Hydrofluoric Acid Etching Gel | Rizhao Huge Biomaterials Company, Ltd. | KLE | Class II | 2024-12-20 |
| K243094 | Quickdent Dental Implant System | Quickdent Devices Private , Ltd. | DZE | Class II | 2024-12-19 |
| K242819 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | NHA | Class II | 2024-12-19 |
| K242892 | Cristaline Aligners Z FLX | Cristaline Aligners GmbH | NXC | Class II | 2024-12-19 |
| K243720 | 3Delta UNlimited | Deltamed GmbH | EBF | Class II | 2024-12-18 |
| K242816 | Quantium | Bisco, Inc. | EBF | Class II | 2024-12-17 |
| K243336 | Lucitone Digital Print Denture System | Dentsply Sirona, Inc. | EBI | Class II | 2024-12-17 |
| K241616 | ALLONUS Tech Prosthetics | Allonus Tech Co., Ltd. | NHA | Class II | 2024-12-17 |
| K243066 | Dental Implants and Abutments | Ditron Dental, Ltd. | DZE | Class II | 2024-12-16 |
| K240735 | visio.lign color, visio.lign shield | Bredent GmbH & Co. KG | EBD | Class II | 2024-12-12 |
| K242934 | Bioceramic Root Canal Sealer and Repair Materials (i-MTA BP) | Longly Biotechnology (Wuhan) Co., Ltd. | KIF | Class II | 2024-12-12 |
| K233152 | GENIOVA aligners | Geniova Technologies Sociedad Limitada | NXC | Class II | 2024-12-12 |
| K242263 | TECHFIT DISRP® System | Techfit Digital Surgery, Inc. | DZJ | Class II | 2024-12-11 |
| K241391 | Straumann® PURE Ceramic Implants | Institut Straumann AG | DZE | Class II | 2024-12-10 |
| K242025 | Elos Accurate® Hybrid Base | Elos Medtech Pinol A/S | NHA | Class II | 2024-12-10 |
| K242703 | LW Pre-milled Abutment | Ossvis Co., Ltd. | NHA | Class II | 2024-12-05 |
| K242740 | Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) | Liaoning Rachcera Material Technology Co., Ltd. | EIH | Class II | 2024-12-05 |
| K242686 | Neodent Implant System | Jjgc Indústria E Comércia DE Materiais Dentários S.A. | NHA | Class II | 2024-12-04 |
| K242185 | Rextar Pro | Raypia Co., Ltd. | EHD | Class II | 2024-12-04 |
| K233273 | C&B Ceramic; C&B Permanent; C&B Interim | Prevest Denpro Limited | EBF | Class II | 2024-11-27 |
| K231859 | PrimmaArt | Dentscare Ltda | EBG | Class II | 2024-11-26 |
| K242559 | Digital Temp | Sprintray, Inc. | EBG | Class II | 2024-11-26 |
| K241692 | MIS LYNX Conical Connection Implant System | Dentsply Sirona, Inc. | DZE | Class II | 2024-11-25 |
| K242245 | Customized Abutment | Arum Dentistry Co., Ltd. | NHA | Class II | 2024-11-25 |
| K242913 | Jasmate® Toothpaste | Jasberry Healthcare Private Limited | LBH | Class II | 2024-11-22 |
| K242884 | Additively Manufactured Denture Resin | Aidite (Qinhuangdao) Technology Co., Ltd. | EBI | Class II | 2024-11-22 |
| K242521 | Estar-ZE | Osstem Implant Co., Ltd. | EIH | Class II | 2024-11-20 |
| K233081 | NUVENTUS NV.C Dental Implant System | Infinitum Eta, Ltd. | DZE | Class II | 2024-11-15 |
| K242360 | Speedex Light Body; Speedex Medium; Speedex Putty; Speedex Putty Soft; Speedex Universal Activator | Dent4you AG | ELW | Class II | 2024-11-15 |
| K240337 | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) | Guangdong Jinme Medical Technology Co., Ltd. | EFB | Class I | 2024-11-13 |
| K242407 | Dental Glass Ceramics Blocks (HT, LT, MT) | Hunan Vsmile Biotechnology Co., Ltd. | EIH | Class II | 2024-11-13 |
| K241074 | High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M) | Foshan Soco Precision Instrument Co., Ltd. | EFB | Class I | 2024-11-12 |
| K241575 | Straumann® Anatomic Healing Abutments XC (AHA) | Straumann USA, LLC | NHA | Class II | 2024-11-11 |
| K242749 | TopCEM Ceramic Primer Ceramic Coupling Agent | Rizhao Huge Biomaterials Company, Ltd. | KLE | Class II | 2024-11-08 |
| K242702 | VioSeal | Spident Co., Ltd. | KIF | Class II | 2024-11-07 |
| K242379 | LL Implant System | Ossvis Co., Ltd. | DZE | Class II | 2024-11-07 |
| K242261 | Accelx Implant System | Biotech Dental, LLC | DZE | Class II | 2024-11-06 |
| K242340 | DESS Dental Smart Solutions | Terrats Medical SL | NHA | Class II | 2024-11-05 |
| K242591 | XERO-alpha | DRTECH Corporation | EHD | Class II | 2024-11-01 |
| K242675 | FineEtch (FineEtch-10 1.2ml, FineEtch-10 5ml, FineEtch-37 1.2ml FineEtch-37 5ml, FineEtch 37% 1.2ml 20ea pack) | Spident Co., Ltd. | KLE | Class II | 2024-11-01 |
| K240383 | Highness Implant System | Highness Co., Ltd. | DZE | Class II | 2024-10-31 |
| K240560 | ZENEX Implant System_Long | Izenimplant Co., Ltd. | DZE | Class II | 2024-10-30 |
| K240040 | VistaPano S Ceph 2.0 (VistaPano S Ceph); VistaPano S 2.0 (VistaPano S); ProVecta S-Pan Ceph 2.0 (ProVecta S-Pan Ceph); ProVecta S-Pan 2.0 (ProVecta S-Pan) | VATECH Co., Ltd. | MUH | Class II | 2024-10-25 |
| K241089 | KeyPrint KeyDenture Base | Keystone Industries | EBI | Class II | 2024-10-24 |
| K242462 | CEREC Cercon 4D CAD/CAM Blocks | Dentsply Sirona | EIH | Class II | 2024-10-24 |
| K242458 | ArgenZ MTZ | Argen Corporation | EIH | Class II | 2024-10-24 |
| K241753 | Immediate Molar Implants | Biomet 3i, LLC | DZE | Class II | 2024-10-23 |
| K241170 | Dynamic TiBase; TRI Screws | Talladium España, SL | NHA | Class II | 2024-10-21 |
| K232994 | Vittra APS Unique Flow | Dentscare Ltda | EBF | Class II | 2024-10-18 |
| K241131 | edelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK; edelweiss CAD/CAM i-BLOCK; Ceramir CAD/CAM T-BLOCK; Ceramir CAD/CAM C-BLOCK; Ceramir CAD/CAM i-BLOCK | Edelweiss Dentistry Products GmbH | EBF | Class II | 2024-10-18 |
| K240725 | PreXolid CAD/CAM abutments | Eclectic Co., Ltd. | NHA | Class II | 2024-10-18 |
| K240321 | MP Pin flat without thread (36BMP000020/MP20) | Hager& Meisinger GmbH | DZL | Class II | 2024-10-17 |
| K241673 | Denture Base Resin (PN-Denture (Red, White)) | Shenzhen Piocreat 3D Technology Co., Ltd. | EBF | Class II | 2024-10-15 |
| K242097 | DenMat Bulk Fill Composite | Den-Mat Holdings, LLC | EBF | Class II | 2024-10-15 |
| K241153 | Progressive Orthodontics App | Progressive Aligners, Inc. | PNN | Class II | 2024-10-11 |
| K242778 | X Sensor (Model: IOS-A15IF, HDI-15DGF) | Qpix Solutions, Inc. | MUH | Class II | 2024-10-11 |
| K240501 | Spark Clear Aligner System | Ormco Corporation | NXC | Class II | 2024-10-11 |
| K240143 | JDZygoma dental implants | Jdentalcare Srl | DZE | Class II | 2024-10-11 |
| K240262 | BTI Interna 3.0 Dental Implant System UnicCa® | B.T.I. Biotechnology Institute, Sl. | DZE | Class II | 2024-10-10 |
| K242400 | Dental porcelain powder | Yilink (Tianjin) Biotechnology Co., Ltd. | EIH | Class II | 2024-10-10 |
| K241485 | TruAbutment DS; TruBase | Truabutment, Inc. | NHA | Class II | 2024-10-09 |
| K242014 | Jet Flow Bulk | Meta Biomed Co., Ltd. | EBF | Class II | 2024-10-08 |
| K240586 | Additive Manufacturing Zirconia Customized Restoration | Hangzhou Thales Medtech Co., Ltd. | ELL | Class II | 2024-10-03 |
| K233497 | Rest Assure System | Somnomed, Inc. | PLC | Class II | 2024-10-03 |
| K241977 | Injectable Root Canal Bioceramic Sealer (i-MTA SP) | Longly Biotechnology (Wuhan) Co., Ltd. | KIF | Class II | 2024-10-03 |
| K240153 | Ceramic Etchant (HF-5 and HF-9) | Liaoning Upcera Co., Ltd. | KLE | Class II | 2024-10-02 |
| K242277 | Crown HT | Sprintray, Inc. | EBF | Class II | 2024-10-01 |
| K241151 | LUXEN 5G | Dentalmax Co., Ltd. | EIH | Class II | 2024-09-30 |
| K241147 | Any-Com | Mediclus Co., Ltd. | EBF | Class II | 2024-09-26 |
| K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) | Nakanishi, Inc. | EFB | Class I | 2024-09-20 |
| K240183 | Star E900 Handpiece Series | Dentalez, Inc., Stardental Division | EGS | Class I | 2024-09-19 |
| K233064 | Copra Supreme | Whitepeaks Dental Solutions GmbH | EIH | Class II | 2024-09-18 |
| K234142 | TiGEN Abutment, PMMA Abutment and Scan Healing Abutment | Megagen Implant Co., Ltd. | NHA | Class II | 2024-09-18 |
| K233721 | KLS Martin Drill-Free MMF Screw | KLS-Martin L.P. | DZL | Class II | 2024-09-17 |
| K240660 | Signum composite flow; Signum universal bond; Signum metal bond ; Signum composite; Signum matrix; Signum liquid; Signum cre-active | Kulzer, LLC | EBF | Class II | 2024-09-17 |
| K234089 | DNA Appliance | Vivos Therapeutics | LRK | Class II | 2024-09-16 |
| K240977 | DenQ Sub SLA Implant System | Denq | DZE | Class II | 2024-09-13 |
| K241722 | Elos Accurate® Hybrid Base; Elos Accurate® Customized Abutment | Elos Medtech Pinol A/S | NHA | Class II | 2024-09-13 |
| K240232 | EK D3.3 and Ultra Wide Implants | Hiossen, Inc. | DZE | Class II | 2024-09-13 |
| K241493 | Glidewell 3DP Denture Base Resin | Prismatik Dentalcraft, Inc. | EBI | Class II | 2024-09-12 |
| K240803 | Surgikor Fixation One, Abutment Blanks and Abutments | Surgikor, LLC | DZE | Class II | 2024-09-12 |
| K232559 | C&B NFH Hybrid | Arum Dentistry Co., Ltd. | EBF | Class II | 2024-09-11 |
| K233921 | Luvis Chair (LC700C) | Dentis Co., Ltd. | KLC | Class I | 2024-09-06 |
| K241579 | DD Hybridlayer (multicolored zirconia) | Dental Direkt GmbH | EIH | Class II | 2024-09-06 |
| K231566 | ICX-Implant System | Medentis Medical GmbH | DZE | Class II | 2024-09-05 |
| K221275 | Qraycam PRO | AIOBIO Co., Ltd. | NBL | Class II | 2024-09-04 |
| K241071 | NextDent Jet Denture Base; NextDent Jet Denture Teeth | Vertex-Dental B.V. | EBI | Class II | 2024-09-04 |
| K231502 | Mini Screws | Proimtech Saglik Urunleri Anonim Sirketi | OAT | Class II | 2024-09-04 |
| K233805 | K5 | Osstem Implant Co., Ltd. Chair Business | EIA | Class I | 2024-09-03 |
| K241602 | Kingcera Dental Zirconia Blank | Hunan Qinghao Puzhong Technology Co., Ltd. | EIH | Class II | 2024-08-30 |
| K241557 | Cercon® yo ML | Dentsply Sirona | EIH | Class II | 2024-08-28 |
| K241457 | Vista BC Putty | Inter-Med, Inc. | KIF | Class II | 2024-08-28 |
| K242537 | BracePaste Fluoride Sealant | American Orthodontics Corp. | DYH | Class II | 2024-08-27 |
12,679 clearances in the Dental panel. Data: openFDA.