Review Panel
Dental FDA 510(k) Clearances & Devices
- Cleared Devices
- 12,679
- Product Codes (page)
- 29
- Latest Decision
- 2018-03-30
Clearances · page 21 of 127
| K-Number | Trade Name | Applicant / Manufacturer | Product Code | Class | Decision Date |
|---|---|---|---|---|---|
| K173379 | Straumann Variobase for Crown AS | Institut Straumann AG | NHA | Class II | 2018-03-30 |
| K170608 | UF(II) Implant System | Dio Corporation | DZE | Class II | 2018-03-30 |
| K173465 | Concentrix MX-AC High-Speed Handpiece | Dentalez, Inc. | EFB | Class I | 2018-03-28 |
| K172760 | REST EAZY Appliance | Insert Molding Solutions, Inc. | LRK | Class II | 2018-03-26 |
| K172354 | OssBuilder System | Osstem Implant Co., Ltd. | JEY | Class II | 2018-03-26 |
| K173120 | CCM Abutment System | Innobiosurg Co., Ltd. | NHA | Class II | 2018-03-16 |
| K172928 | Portable X-ray System | Rolence Enterprise, Inc. | EHD | Class II | 2018-03-16 |
| K180404 | 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System | 3M Healthcare | NJM | Class II | 2018-03-16 |
| K173326 | MIS CONNECT Conical Connection Abutment | Mis Implants Technologies , Ltd. | NHA | Class II | 2018-03-16 |
| K173785 | Custom Clear Aligner System | Derby Dental Laboratory | NXC | Class II | 2018-03-13 |
| K173440 | Carriere SLX 3D Clear | Ortho Organizers, Inc. | NJM | Class II | 2018-03-08 |
| K173769 | DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid | Dmax Co., Ltd. | EIH | Class II | 2018-03-08 |
| K171150 | AW-100 | Micron Corporation | ELC | Class II | 2018-03-08 |
| K173500 | NMF004A | GC America, Inc. | EBF | Class II | 2018-03-08 |
| K172810 | PORT-X IV | Genoray Co., Ltd. | EHD | Class II | 2018-03-07 |
| K173275 | OMNICHROMA | Tokuyama Dental Corporation | EBF | Class II | 2018-02-27 |
| K173343 | Zygomatic Implant System | Southern Implants (Pty), Ltd. | DZE | Class II | 2018-02-27 |
| K170175 | ENDOSEAL MTA | Maruchi | KIF | Class II | 2018-02-26 |
| K173643 | Trilor Disks, Blocks and Arches | Bioloren S.R.L. | EBF | Class II | 2018-02-24 |
| K173320 | KLS Martin L1 MMF System | KLS Martin L.P. | JEY | Class II | 2018-02-23 |
| K171649 | Straumann CARES M-Series CAD/CAM System | Institut Straumann AG | NHA | Class II | 2018-02-22 |
| K171576 | The Panthera Anti-Snoring X3 Device | Panthera Dental, Inc. | LRK | Class II | 2018-02-22 |
| K173402 | Neocis Guidance System (NGS) with Chairside Splint | Neocis, Inc. | PLV | Class II | 2018-02-22 |
| K172839 | ENDOSOLV | Septodont | KIF | Class II | 2018-02-13 |
| K170131 | TAV Medical Dental Implants System | Tav Medical , Ltd. | DZE | Class II | 2018-02-10 |
| K171179 | BR Type Implant System | Biotem Co., Ltd. | DZE | Class II | 2018-02-09 |
| K180107 | Blue Sky Bio Aligner | Blue Sky Bio, LLC | NXC | Class II | 2018-02-09 |
| K172160 | Southern Implants PEEK Abutments | Southern Implants (Pty), Ltd. | NHA | Class II | 2018-02-09 |
| K172953 | Acid Etchant | American Orthodontics | KLE | Class II | 2018-02-06 |
| K161989 | PREMIUM Implant Systems SHELTA Implant Systems | Sweden & Martina S.P.A. | NHA | Class II | 2018-02-01 |
| K172240 | SPI Dental Implant System | Msi France | DZE | Class II | 2018-01-31 |
| K171772 | Ecosite Bulk Fill | Dmg USA, Inc. | EBF | Class II | 2018-01-31 |
| K172845 | Symetri Clear | Ormco Corporation | NJM | Class II | 2018-01-31 |
| K171297 | AR_N Type Implant System | Biotem Co., Ltd. | DZE | Class II | 2018-01-31 |
| K173466 | Panthera Dental Milled Bars | Panthera Dental, Inc. | NHA | Class II | 2018-01-26 |
| K173876 | Cybird LED Curing Light | Dxm Co., Ltd. | EBZ | Class II | 2018-01-24 |
| K172304 | TruAbutment DS | Truabutment, Inc. | NHA | Class II | 2018-01-23 |
| K171674 | Angel Align System | Smile Development Corp | NXC | Class II | 2018-01-19 |
| K171784 | Straumann Dental Implant System | Straumann USA, LLC | DZE | Class II | 2018-01-19 |
| K171634 | Ortho System | 3Shape A/S | PNN | Class II | 2018-01-17 |
| K172164 | PROPEL Device | Propel Orthodontics, LLC | DZJ | Class II | 2018-01-17 |
| K173020 | OBA-MCP, Orthodontic Bracket Adhesive with MCP | Pulpdent Corporation | DYH | Class II | 2018-01-17 |
| K172977 | Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel | Nanova Biomaterials, Inc. | KLE | Class II | 2018-01-16 |
| K172683 | Yamahachi Pink CAD/CAM Disk | YAMAHACHI DENTAL MFG., Co. | EBI | Class II | 2018-01-16 |
| K171799 | Elos Accurate Customized Abutment, Elos Prosthetic Screw | Elos Medtech Pinol A/S | NHA | Class II | 2018-01-15 |
| K171958 | PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE | Mectron S.P.A. | DZI | Class II | 2018-01-12 |
| K170421 | ET Hybrid Abutment | Hiossen, Inc. | NHA | Class II | 2018-01-11 |
| K171622 | Dentium Ti-Base | Dentium Co., Ltd. | NHA | Class II | 2018-01-11 |
| K171122 | CEREC Ortho Software | Dentsply Sirona | PNN | Class II | 2018-01-11 |
| K171295 | ULab Systems Treatment Planning Software | Ulab Systems, Inc. | PNN | Class II | 2018-01-09 |
| K172169 | Pulpdent (Activa) Pit and Fissure Sealant with MCP | Pulpdent Corporation | EBC | Class II | 2018-01-05 |
| K171860 | Sureclear aligners | Emergo Global Consulting, LLC | NXC | Class II | 2018-01-05 |
| K171436 | STRONG Dental Handpieces | Saeshin Precision Co., Ltd. | EGS | Class I | 2018-01-05 |
| K172701 | BIO-C SEALER | Angelus Industria DE Produtos Odontologicos S/A | KIF | Class II | 2018-01-04 |
| K172798 | Straumann CARES Abutments CoCr | Institut Straumann AG | NHA | Class II | 2018-01-03 |
| K171529 | Snorer's Friend | Scope Healthcare Technologies Pty, Ltd. | LRK | Class II | 2018-01-02 |
| K172505 | MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments | Mis Implants Technologies , Ltd. | DZE | Class II | 2017-12-28 |
| K170104 | COMPACT S, COMPACT S (LED) | Dmetec.Co., Ltd. | ELC | Class II | 2017-12-27 |
| K172560 | PREMIUM ONE Implant Systems | Sweden & Martina S.P.A. | DZE | Class II | 2017-12-21 |
| K170950 | Well-Root ST | Vericom Co., Ltd. | KIF | Class II | 2017-12-20 |
| K173646 | FS Ergo | Palodex Group OY | MUH | Class II | 2017-12-19 |
| K171174 | PERIO-FLOW nozzle | E.M.S Electro Medical Systems S.A | EFB | Class I | 2017-12-18 |
| K172918 | DEXIS Titanium, KaVo IXS HD (Size 1, Size 2) | Kavo Dental Technologies, LLC | MUH | Class II | 2017-12-18 |
| K173124 | PEEK Biosolution | Merz Dental GmbH | EBF | Class II | 2017-12-18 |
| K172854 | NobelPerfect Abutments | Nobel Biocare AB | NHA | Class II | 2017-12-14 |
| K171167 | Prodigio Stain Powder | Operart, LLC | EIH | Class II | 2017-12-13 |
| K173374 | TSV BellaTek Encode Healing Abutments | Biomet 3i | NHA | Class II | 2017-12-13 |
| K171729 | Fixtemp C&B | Dreve Dentamid GmbH | EBG | Class II | 2017-12-13 |
| K171553 | W&H Assistina Twin | W&H Dentalwerk Buermoos GmbH | EFB | Class I | 2017-12-08 |
| K172530 | BEAUTIFIL Flow Plus X | Shofu Dental Corporation | EBF | Class II | 2017-12-06 |
| K172707 | Renamel Microfill | Cosmedent, Inc. | EBF | Class II | 2017-12-05 |
| K170392 | S.I.N. Implant System | S.I.N. Sistema DE Implante Nacional S.A. | DZE | Class II | 2017-12-01 |
| K171773 | Straumann n!ce Glass Ceramic A14 Blocks | Institut Straumann AG | NHA | Class II | 2017-12-01 |
| K171185 | IR Type Implant System | Biotem Co., Ltd. | DZE | Class II | 2017-12-01 |
| K172225 | Atlantis Abutment for MIS Implant | Dentsply Sirona | NHA | Class II | 2017-11-30 |
| K171466 | NobelDesign, DTX Studio Design | Nobel Biocare AB | NHA | Class II | 2017-11-29 |
| K171694 | s-Clean TiN Coating Abutments | Dentis Co., Ltd. | NHA | Class II | 2017-11-29 |
| K161652 | DIAZIR | Zxtgy (Beijing) Technology Co., Ltd. | EIH | Class II | 2017-11-28 |
| K170053 | Meridian PM | The Center For Craniofacial & Dental Sleep Medicine | LRK | Class II | 2017-11-28 |
| K171226 | TOKUYAMA UNIVERSAL BOND | Tokuyama Dental Corporation | KLE | Class II | 2017-11-28 |
| K171757 | Straumann Screw Retained Abutments | Straumann USA, LLC (On Behalf of Institut Straumann Ag) | NHA | Class II | 2017-11-27 |
| K161855 | LED Curing Light | Monitex Industrial Co., Ltd. | EBZ | Class II | 2017-11-27 |
| K170578 | True Function Adjustable Herbst Appliances | True Function Laboratory, Inc. | LRK | Class II | 2017-11-24 |
| K172398 | DENTCA DENTURE Teeth | Dentca, Inc. | PZY | Class II | 2017-11-22 |
| K172007 | CamX Triton HD Proxi Head | Duerr Dental AG | NTK | Class II | 2017-11-22 |
| K172576 | BioHorizons Tapered Short Implants | BioHorizons Implant Systems, Inc. | DZE | Class II | 2017-11-22 |
| K172859 | Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder | Prosomnous Sleep Technologies | PLC | Class II | 2017-11-22 |
| K170236 | Dental Low-speed Turbine Handpiece | Guangdong Jinme Medical Technology Co., Ltd. | EFB | Class I | 2017-11-21 |
| K163579 | KLS Martin Individual Patient Solutions | KLS Martin L.P. | JEY | Class II | 2017-11-21 |
| K172176 | Parkell Universal Adhesive | Parkell, Inc. | KLE | Class II | 2017-11-21 |
| K170398 | S.I.N. Dental Implant System | S.I.N. Sistema DE Implante Nacional S.A. | DZE | Class II | 2017-11-21 |
| K163414 | Ultrasonic scaler | Nanning VV Dental Co., Ltd. | ELC | Class II | 2017-11-21 |
| K171155 | Surgical Angle Handpiece, Surgical Straight Handpiece | Nakanishi, Inc. | KMW | Class II | 2017-11-21 |
| K172761 | New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded) | Shanghai New Century Dental Materials Co., Ltd. | EIH | Class II | 2017-11-17 |
| K173319 | KaVo NOMAD Pro 2 Handheld X-ray System | Aribex | EHD | Class II | 2017-11-16 |
| K170606 | Acrylic Herbst Appliance with Micro-Recorder | Gergen'S Orthodontic Lab | PLC | Class II | 2017-11-16 |
| K171254 | LeEject 2 Dental Syringe and Needle System | Advanced Technology and Capital, Inc. | EJI | Class II | 2017-11-16 |
| K170022 | Klockner Vega TiBase for CEREC | SOADCO, S.L. | NHA | Class II | 2017-11-16 |
| K171815 | Registrado Scan | Voco GmbH | EBF | Class II | 2017-11-15 |
| K173410 | n!ce for Planmill | Institut Straumann AG | EIH | Class II | 2017-11-14 |
12,679 clearances in the Dental panel. Data: openFDA.