Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 39
- Latest Decision
- 2020-11-09
Clearances · page 15 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K200005 | Concinnity Aligners | Drake Precision Dental Laboratory, Inc. | NXC | Class II | 2020-11-09 |
| K200077 | BioMin Restore Plus | Dr. Collins, Inc. | LBH | Class II | 2020-11-06 |
| K202664 | Clio Prime and Clio Pedo | Sota Precision Optics, Inc. Dba Sota Imaging | MUH | Class II | 2020-11-06 |
| K201827 | GR-17 Resin System | Pro3Dure Medical GmbH | EBG | Class II | 2020-11-05 |
| K193499 | DigiGuide System | Protomed, Inc. | DZJ | Class II | 2020-11-04 |
| K201683 | PMMA Block | Huge Dental Material Co., Ltd. | EBG | Class II | 2020-11-03 |
| K193090 | HCG Zirconia Ceramic Block | Hocheng Corporation | EIH | Class II | 2020-10-29 |
| K192282 | MedCAD® AccuPlan® System | Medcad | DZJ | Class II | 2020-10-29 |
| K200153 | Bright Bond Universal | Genoss Co., Ltd. | KLE | Class II | 2020-10-28 |
| K202960 | General Cutting Contra Handpiece | Nakanishi, Inc. | EGS | Class I | 2020-10-27 |
| K193084 | TIB Abutment System | Southern Implants (Pty), Ltd. | NHA | Class II | 2020-10-27 |
| K200156 | Bright Low Flow | Genoss Co., Ltd. | EBF | Class II | 2020-10-27 |
| K200273 | FREEPRINT temp | Detax GmbH & Co. KG | EBG | Class II | 2020-10-27 |
| K193623 | DIOnavi-Denture | Dio Corporation | EBI | Class II | 2020-10-22 |
| K181477 | MS Lide Implant Systems | Hangzhou Minsheng Lide Medical Science & Technology Co., Ltd. | DZE | Class II | 2020-10-20 |
| K202100 | Neocis Guidance System (NGS) with Clamped Chairside Patient Splint (C-CPS) | Neocis, Inc. | PLV | Class II | 2020-10-19 |
| K200906 | MINICONE Implant | Medentika GmbH | DZE | Class II | 2020-10-16 |
| K200386 | Z5-BL | Z-Systems AG | DZE | Class II | 2020-10-14 |
| K201038 | Luce Ceramic Bracket | Luce Castle Co., Ltd. | NJM | Class II | 2020-10-09 |
| K201483 | Impression Material | Zhengzhou Huaer Electro Optics Technology Co., Ltd. | ELW | Class II | 2020-10-08 |
| K200817 | URIS OMNI Narrow System & Prosthetic | Truabutment, Inc. | DZE | Class II | 2020-10-07 |
| K202633 | ScanX Edge | Dürr Dental SE | MUH | Class II | 2020-10-07 |
| K200100 | Abutment Design | 3Shape A/S | PNP | Class II | 2020-10-07 |
| K201561 | Membrane Screws and Membrane Tacks | Neoss Limited | DZL | Class II | 2020-10-05 |
| K201238 | Encore System | Siesta Medical, Inc. | ORY | Class II | 2020-10-02 |
| K200623 | OssGuide | Sk Bioland Co., Ltd. | NPL | Class II | 2020-10-02 |
| K201546 | OsOpia Synthetic Bone Void Filler | Revisios BV | LYC | Class II | 2020-10-02 |
| K200682 | BZF-29 | GC America, Inc. | KLE | Class II | 2020-10-02 |
| K191320 | Slow Wave DS8 | Slow Wave, Inc. | LQZ | Class II | 2020-10-02 |
| K193401 | Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants | Altatec GmbH | DZE | Class II | 2020-09-29 |
| K201790 | Dual Cure Resin Cement | Rizhao Huge Biomaterials Company, Ltd. | EMA | Class II | 2020-09-29 |
| K201795 | Transcend | Ultradent Product, Inc. | EBF | Class II | 2020-09-28 |
| K202685 | Eon Aligner | Eon Dental Jordan, LLC | NXC | Class II | 2020-09-28 |
| K202039 | Honorst Implant System | Medimecca Co., Ltd. | DZE | Class II | 2020-09-25 |
| K201787 | Light Cure Dental Adhesive | Rizhao Huge Biomaterials Company, Ltd. | KLE | Class II | 2020-09-25 |
| K201051 | Straumann BoneCeramic | Institut Straumann AG | LYC | Class II | 2020-09-24 |
| K201684 | A-Silicone for Bite Registration | Shandong Huge Dental Material Corporation | ELW | Class II | 2020-09-24 |
| K202479 | IBS Implant System | Innobiosurg Co., Ltd. | DZE | Class II | 2020-09-23 |
| K200174 | DIA-ROOT BIO MTA | DiaDent Group International | KIF | Class II | 2020-09-18 |
| DEN190039 | ToothWave | Home Skinovations , Ltd. | QMJ | Class II | 2020-09-17 |
| K201859 | Porcine Mineral Collagen Composite Moldable | Collagen Matrix, Inc. | NPM | Class II | 2020-09-11 |
| K201450 | Straight T Clear Dental Aligner | Straight T, Inc. | NXC | Class II | 2020-09-10 |
| K201944 | DePuy Synthes 2.4mm Ti Self-Tapping MatrixMANDIBLE Screws (26-40mm) | Synthes (USA) Products, LLC | JEY | Class II | 2020-09-10 |
| K193212 | DSM Biomedical Dental Bone Graft Plus | Dsm Biomedical | NPM | Class II | 2020-09-10 |
| K201090 | Structur CAD | Voco GmbH | EBG | Class II | 2020-09-09 |
| K201225 | Neodent Implant System - GM Helix Implants 7.0 | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | DZE | Class II | 2020-09-04 |
| K193341 | iCTmotor (WL-1) | Dentium Co., Ltd. | EBW | Class I | 2020-09-04 |
| K200102 | MIS Dental Implant System | Dentsply Sirona | DZE | Class II | 2020-09-03 |
| K202499 | Diamond Digital Sleep Orthotic (DDSO) | Diamond Orthotic Laboratory | LRK | Class II | 2020-09-03 |
| K193405 | Simplant Digital Guide | Dentsply Sirona | NDP | Class I | 2020-09-02 |
| K200462 | EtchPro Etching Gel | Belport Company, Inc., Gingi-Pak | KLE | Class II | 2020-09-02 |
| K200827 | LOCATOR R-Tx | Ivory Super Holdco, Incp. | NHA | Class II | 2020-09-02 |
| K192830 | Bright Temporary C&B | Dmp Dental Industry S.A. | EBG | Class II | 2020-09-02 |
| K191041 | Orthodontic Fixation Screw [Smart Anchor Miniscrew] | Gni Co., Ltd. | OAT | Class II | 2020-08-28 |
| K200881 | Oral-B iO Test Drive Power Brush Trial Program Kit | The Procter & Gamble Company | JEQ | Class I | 2020-08-27 |
| K201981 | Magicore System | Innobiosurg Co., Ltd. | DZE | Class II | 2020-08-27 |
| K192062 | Nucleoss T6 Dental Implant System | Sanlilar Tibbi Cihazlar Medikal Kimya Sanayi Ticaret Ltd. ST | DZE | Class II | 2020-08-27 |
| K201856 | Provicol QM Aesthetic | Voco GmbH | EMA | Class II | 2020-08-26 |
| K192809 | Dental Handpiece | Micro-Nx Co., Ltd. | EFA | Class I | 2020-08-25 |
| K193260 | U-Cem Premium & MAZIC Cem | Vericom Co., Ltd. | EMA | Class II | 2020-08-21 |
| K200586 | Straumann TLX Implant System | Institut Straumann AG | DZE | Class II | 2020-08-20 |
| K200597 | Straumann BLX Gold Abutments | Straumann USA, LLC (On Behalf of Institut Straumann Ag) | NHA | Class II | 2020-08-19 |
| K193537 | Omnichroma Flow | Tokuyama Dental Corporation | EBF | Class II | 2020-08-19 |
| K200191 | Sirona Dental CAD/CAM System with InLab Software | Dentsply Sirona | PNP | Class II | 2020-08-19 |
| K191591 | BB Base 3D printing resin for denture base | Enlighten Materials Co., Ltd. | EBI | Class II | 2020-08-18 |
| K201334 | Keystone Dental XL Dental Implant System | Keystone Dental, Inc. | DZE | Class II | 2020-08-18 |
| K192723 | Coloring Liquid | Aidite (Qinhuangdao) Technology Co., Ltd. | EIH | Class II | 2020-08-18 |
| K192597 | Cytrans Granules | GC America, Inc. | LYC | Class II | 2020-08-17 |
| K193408 | Sirona Dental CAD/CAM System with CEREC Chairside Software | Dentsply Sirona | NHA | Class II | 2020-08-16 |
| K192682 | Orthocem, Ortho Bite | Dentscare Ltda | DYH | Class II | 2020-08-14 |
| K202276 | BracePaste Band and Build LC | American Orthodontics | DYH | Class II | 2020-08-14 |
| K200775 | LOOP LED Curing Light System | Garrison Dental Solutions, LLC | EBZ | Class II | 2020-08-14 |
| K201010 | Infinix Universal Composite, Infinix Flowable Composite, Infinix Bulk Fill Flow Composite | Nobio , Ltd. | EBF | Class II | 2020-08-14 |
| K193046 | Straumann® Retentive System Novaloc TiN Abutments | Institut Straumann AG | NHA | Class II | 2020-08-13 |
| K193264 | Disposable High Speed Air Turbine Handpiece | Ningbo Hpdove Dental Instruments Co., Ltd. | EFB | Class I | 2020-08-11 |
| K193130 | MVP Aligner System | Mvp Aligners, LLC | NXC | Class II | 2020-08-07 |
| K200809 | D-LUX+ | DiaDent Group International | EBZ | Class II | 2020-08-07 |
| K190790 | Flex Fit | Dk Mungyo Corporation | EBI | Class II | 2020-07-31 |
| K192294 | I Do | I DO Biotech Co., Ltd. | DZE | Class II | 2020-07-31 |
| K200039 | P pro Crown & Bridge | Deltamed GmbH | EBG | Class II | 2020-07-31 |
| K182759 | BoniPlus Dental G-Mesh System | Montjade Engineering Co., Ltd. | JEY | Class II | 2020-07-29 |
| K200805 | Neocis Guidance System (NGS) with Patient Splints | Neocis, Inc. | PLV | Class II | 2020-07-28 |
| K200355 | Duranext Abutments | Elegant Dental Corp. | NHA | Class II | 2020-07-22 |
| K193434 | VITA LUMEX AC | Vita Zahnfabrik GmbH H Rauter & CO | EIH | Class II | 2020-07-21 |
| K192847 | AUTOLIGN | Diorco Co., Ltd. | PNN | Class II | 2020-07-21 |
| K201621 | Magicore II System | Innobiosurg Co., Ltd. | NHA | Class II | 2020-07-15 |
| K192561 | TRAUS SUS20 | Saeshin Precision Co., Ltd. | DZI | Class II | 2020-07-13 |
| K193113 | GC Temp Print | GC America, Inc. | EBG | Class II | 2020-07-09 |
| K200676 | ABRO 1, RESITON GINGIVA, PRIME and THERAPON TRANSPA | Zirkonzahn Srl | EBG | Class II | 2020-07-08 |
| K192231 | Dental Glass Ceramics Blocks | Aidite (Qinhuangdao) Technology Co., Ltd. | EIH | Class II | 2020-07-08 |
| K201307 | VisCalor | Voco GmbH | EBF | Class II | 2020-07-08 |
| K191152 | MIS Ti-base Abutment | Dentsply Sirona | NHA | Class II | 2020-07-06 |
| K183471 | IC-WHCD100 (Inspire) | Good Doctors Co., Ltd. | NBL | Class II | 2020-07-02 |
| K193484 | GC Fuji Triage EP | GC America, Inc. | EMA | Class II | 2020-07-02 |
| K191276 | Dental Electrical Motor iRoot Pro | Changzhou Bomedent Medical Technology Co.,Ltd | EKX | Class I | 2020-06-30 |
| K200265 | Surgical Drills | Implant Direct Sybron Manufacturing, LLC | DZI | Class II | 2020-06-30 |
| K182081 | JDentalCare Implant System JDIcon | Jdentalcare Srl | DZE | Class II | 2020-06-26 |
| K191443 | MSDI Dental Implants System | Medical Systems and Devices International , Ltd. | DZE | Class II | 2020-06-26 |
| K200614 | FiteBac Antimicrobial Cavity Cleanser | Largent Health, LLC | LBH | Class II | 2020-06-25 |
| K200175 | DIA-ROOT BIO Sealer | DiaDent Group International | KIF | Class II | 2020-06-25 |
12,679 clearances in the Dental panel. Data: openFDA.