| 代码 | 器械名称 | 类别 | 21 CFR | 近三年 510(k) |
|---|
| KLE | Agent, Tooth Bonding, Resin | 第 2 类 | 21 CFR 872.3200 | 419 |
| KMT | Tray, Fluoride, Disposable | 第 1 类 | 21 CFR 872.6870 | 8 |
| KMW | Handpiece, Rotary Bone Cutting | 第 2 类 | 21 CFR 872.4120 | 9 |
| KMY | Positioner, Tooth, Preformed | 第 1 类 | 21 CFR 872.5525 | 12 |
| KOJ | Airbrush | 第 2 类 | 21 CFR 872.6080 | 48 |
| KOK | Sterilizer, Endodontic Dry Heat | 第 3 类 | 21 CFR 872.6730 | |
| KOL | Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Ox | 第 1 类 | 21 CFR 872.3410 | 2 |
| KOM | Adhesive, Denture, Acacia And Karaya With Sodium Borate | 第 1 类 | 21 CFR 872.3400 | 1 |
| KON | Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic) | 第 3 类 | 21 CFR 872.3480 | |
| KOO | Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Do | 第 1 类 | 21 CFR 872.3490 | 4 |
| KOP | Adhesive, Denture, Karaya | 第 1 类 | 21 CFR 872.3450 | 1 |
| KOQ | Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&) | 第 1 类 | 21 CFR 872.3410 | 4 |
| KOR | Adhesive, Denture, Karaya With Sodium Borate | 第 3 类 | 21 CFR 872.3400 | |
| KOS | Adhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacry | 第 3 类 | 21 CFR 872.3420 | |
| KOT | Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Cal | 第 1 类 | 21 CFR 872.3490 | 8 |
| KXR | Applicator, Resin | 第 1 类 | 21 CFR 872.3140 | 3 |
| KXW | Adhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Ox | 第 1 类 | 21 CFR 872.3410 | |
| KXX | Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer | 第 1 类 | 21 CFR 872.3450 | 1 |
| KXY | Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxyme | 第 3 类 | 21 CFR 872.3500 | |
| KZN | Scanner, Color | 第 2 类 | 21 CFR 872.3661 | 2 |
| KZO | Ink, Arch Tracing | 第 1 类 | 21 CFR 872.3150 | 2 |
| KZP | Solution, Cement Dissolving | 第 2 类 | 21 CFR 872.3750 | 2 |
| LBH | Varnish, Cavity | 第 2 类 | 21 CFR 872.3260 | 138 |
| LCN | Scraper, Tongue | 第 1 类 | 21 CFR 872.6855 | 31 |
| LFC | Device, Caries Detection | 第 2 类 | 21 CFR 872.1740 | 17 |
| LQZ | Device, Jaw Repositioning | 第 2 类 | 21 CFR 872.5570 | 27 |
| LRK | Device, Anti-Snoring | 第 2 类 | 21 CFR 872.5570 | 215 |
| LTF | Stimulator, Salivary System | 第 2 类 | 21 CFR 872.5560 | 2 |
| LYC | Bone Grafting Material, Synthetic | 第 2 类 | 21 CFR 872.3930 | 231 |
| LZD | Joint, Temporomandibular, Implant | 第 3 类 | 21 CFR 872.3940 | |
| MAU | Eraser, Dental Stain | 第 1 类 | 21 CFR 872.6855 | 2 |
| MCF | Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Sterile | 第 1 类 | 21 CFR 872.6855 | 5 |
| MDL | Implant, Transmandibular | 第 2 类 | 21 CFR 872.4760 | 2 |
| MEF | Ring, Teething, Non-Fluid Filled | 第 1 类 | 21 CFR 872.5550 | 1 |
| MMD | Toothbrush, Ionic, Battery-Powered | 第 1 类 | 21 CFR 872.6865 | 2 |
| MMT | Resin, Root Canal Filling Containing Chloroform | 第 3 类 | 21 CFR 872.3820 | |
| MMU | Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weigh | 第 3 类 | 21 CFR 872.3400 | |
| MPI | Glenoid Fossa Prosthesis | 第 3 类 | 21 CFR 872.3950 | |
| MPJ | Interarticular Disc Prosthesis (Interpositional Implant) | 第 3 类 | 21 CFR 872.3970 | |
| MPL | Mandibular Condyle Prosthesis | 第 3 类 | 21 CFR 872.3960 | |
| MQN | External Mandibular Fixator And/Or Distractor | 第 2 类 | 21 CFR 872.4760 | 60 |
| MUH | System, X-Ray, Extraoral Source, Digital | 第 2 类 | 21 CFR 872.1800 | 206 |
| MVH | Device, Detection, Sulfide | 第 2 类 | 21 CFR 872.1870 | 1 |
| MXF | System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation | 第 2 类 | 21 CFR 872.4120 | 5 |
| MYB | Pillow, Cervical (For Mild Sleep Apnea) | 第 2 类 | 21 CFR 872.5570 | 6 |
| MZW | Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain R | 第 2 类 | 21 CFR 872.3275 | 2 |
| NBL | Light-Induced Fluorescence Caries Detector | 第 2 类 | 21 CFR 872.1745 | 24 |
| NDP | Accessories, Implant, Dental, Endosseous | 第 1 类 | 21 CFR 872.3980 | 4 |
| NEA | Cement, Ear, Nose And Throat | 第 2 类 | 21 CFR 872.3275 | 6 |
| NEI | Prosthesis, Condyle, Mandibular, Temporary | 第 2 类 | 21 CFR 872.4770 | 7 |
| NFE | Materials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial | 第 2 类 | 21 CFR 872.3680 | |
| NFP | Device, Dental Sonography, For Diagnosis Of Tmj / Mpd Disorders | 第 2 类 | 21 CFR 872.2050 | |
| NFQ | Device, Dental Sonography, For Monitoring Jaw Sounds | 第 1 类 | 21 CFR 872.2050 | 4 |
| NFR | Device, Jaw Tracking, For Diagnosis Of Tmj / Mpd Disorders | 第 2 类 | 21 CFR 872.2060 | |
| NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | 第 1 类 | 21 CFR 872.2060 | 2 |
| NHA | Abutment, Implant, Dental, Endosseous | 第 2 类 | 21 CFR 872.3630 | 713 |
| NJM | Bracket, Ceramic, Orthodontic | 第 2 类 | 21 CFR 872.5470 | 60 |
| NKJ | Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter | 第 1 类 | 21 CFR 872.3540 | |
| NLC | Bracket, Plastic, Orthodontic, Reprocessed | 第 2 类 | 21 CFR 872.5470 | |
| NLD | Instrument, Diamond, Dental, Reprocessed | 第 1 类 | 21 CFR 872.4535 | |
| NME | Bur, Diamond Coated, Reprocessed | 第 1 类 | 21 CFR 872.3240 | |
| NMW | Needle, Dental, Reprocessed | 第 1 类 | 21 CFR 872.4730 | |
| NOB | Unit, Ultraviolet Sanitation/Sterilization (For Toothbrushes), Non-Ste | 第 1 类 | 21 CFR 872.6855 | |
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing | 第 2 类 | 21 CFR 872.3661 | 5 |
| NPK | Barrier, Synthetic, Intraoral | 第 2 类 | 21 CFR 872.3930 | 31 |
| NPL | Barrier, Animal Source, Intraoral | 第 2 类 | 21 CFR 872.3930 | 57 |
| NPM | Bone Grafting Material, Animal Source | 第 2 类 | 21 CFR 872.3930 | 40 |
| NPZ | Bone Grafting Material, Dental, With Biologic Component | 第 3 类 | 21 CFR 872.3930 | |
| NQA | Biologic Material, Dental | 第 3 类 | 21 CFR 872.3930 | |
| NQS | Bracket, Metal, Orthodontic, Reprocessed | 第 1 类 | 21 CFR 872.5410 | |
| NRD | Unit, Operative Dental, Accessories | 第 1 类 | 21 CFR 872.6640 | 2 |
| NRQ | Blade-Form Endosseous Dental Implant | 第 2 类 | 21 CFR 872.3640 | 5 |
| NRU | Chair, Dental, Without Operative Unit | 第 1 类 | 21 CFR 872.6250 | |
| NSB | Patient Personal Hygiene Kit | 第 1 类 | 21 CFR 872.6855 | |
| NTK | Light Transmission Caries Detector | 第 2 类 | 21 CFR 872.1745 | 12 |
| NTO | Rinse, Oral, Antibacterial (By Physical Means) | 第 2 类 | 21 CFR 872.5580 | 2 |
| NUN | Bone Grafting Material, Human Source | 第 2 类 | 21 CFR 872.3930 | 15 |
| NUX | Cleanser, Denture, Prescription | 第 1 类 | 21 CFR 872.3520 | |
| NXC | Aligner, Sequential | 第 2 类 | 21 CFR 872.5470 | 145 |
| NXV | Diagnostic Light, Soft Tissue Detector | 第 2 类 | 21 CFR 872.6350 | 12 |
| NXZ | Dental Hygiene Kit | 第 1 类 | 21 CFR 872.6855 | |
| NYC | Dental Prophylaxis Kit | 第 1 类 | 21 CFR 872.4565 | |
| NYD | Endodontic Kit | 第 2 类 | 21 CFR 872.3820 | |
| NYE | Fixture Mount Kit | 第 1 类 | 21 CFR 872.3980 | |
| NYF | Gingival Retraction Kit | 第 1 类 | 21 CFR 872.4565 | |
| NYG | Lapping Tool Kit | 第 1 类 | 21 CFR 872.4565 | |
| NYH | Plaque Disclosing Kit | 第 2 类 | 21 CFR 872.1740 | 1 |
| NYL | Handpiece, Air-Powered, Root Canal Irrigation | 第 1 类 | 21 CFR 872.4200 | 5 |
| OAT | Implant, Endosseous, Orthodontic | 第 2 类 | 21 CFR 872.3640 | 52 |
| OFW | Restorative Instrument And Component Tray | 第 2 类 | 21 CFR 872.3690 | |
| OFX | General Purpose Dental Tray | 第 1 类 | 21 CFR 872.6640 | |
| OFY | Dental Implant Surgical Tray | 第 1 类 | 21 CFR 872.3980 | |
| OGT | Oral Irrigation Kit | 第 1 类 | 21 CFR 872.6510 | |
| OHP | Expiratory Resistance Valve, Intranasal, For Obstructive Sleep Apnea | 第 2 类 | 21 CFR 872.5570 | 5 |
| OIV | Dental Amalgam | 第 2 类 | 21 CFR 872.3070 | 3 |
| ORY | Tongue Suspension System | 第 2 类 | 21 CFR 872.5570 | 10 |
| OYH | Orthodontic Vibratory Accessory | 第 2 类 | 21 CFR 872.5470 | 5 |
| OZR | Intraoral Pressure Gradient Device | 第 2 类 | 21 CFR 872.5570 | 6 |
| PFL | Intraoral, Dental Foam Protector | 第 1 类 | 21 CFR 872.6890 | 1 |
| PHR | Diammine Silver Fluoride Dental Hypersensitivity Varnish | 第 2 类 | 21 CFR 872.3260 | 8 |
| PIP | Prophy Powder, Airbrush Accessory | 第 2 类 | 21 CFR 872.6080 | 2 |
| PLC | Sleep Appliances With Patient Monitoring | 第 2 类 | 21 CFR 872.5570 | 10 |
| PLH | Orthodontic Led Accessory | 第 2 类 | 21 CFR 872.5470 | 2 |
| PLV | Dental Stereotaxic Instrument | 第 2 类 | 21 CFR 872.4120 | 23 |
| PME | External Cleaning Solution | 第 2 类 | 21 CFR 872.3260 | 3 |
| PNN | Orthodontic Software | 第 2 类 | 21 CFR 872.5470 | 34 |
| PNP | Dental Abutment Design Software For Dental Laboratory | 第 2 类 | 21 CFR 872.3630 | 8 |
| POW | Crown And Bridge, Long-Term Temporary, Resin | 第 2 类 | 21 CFR 872.3770 | 2 |
| PWL | Oral Surgery Tray | 第 1 类 | 21 CFR 872.4565 | |
| PZY | Additively Manufactured, Preformed, Resin Denture Tooth | 第 2 类 | 21 CFR 872.3590 | 1 |
| QCJ | Closed Loop Auto Titration Device For Oral Appliances | 第 2 类 | 21 CFR 872.5571 | 1 |
| QGO | Composite Resin Warmer | 第 1 类 | 21 CFR 872.6100 | 1 |
| QIA | Powered Tongue Scraper | 第 1 类 | 21 CFR 872.6865 | 1 |
| QJC | Plaque Disclosing Agent | 第 1 类 | 21 CFR 872.6855 | 1 |
| QJJ | Indirect Bonding Tray | 第 1 类 | 21 CFR 872.5410 | |
| QJK | Intraoral Camera | 第 2 类 | 21 CFR 872.3661 | |
| QMJ | Powered Radiofrequency Toothbrush | 第 2 类 | 21 CFR 872.6866 | 2 |
| QNF | Laser Activator For Polymerization | 第 2 类 | 21 CFR 872.6070 | 2 |
| QNO | Neuromuscular Tongue Muscle Stimulator For The Reduction Of Snoring An | 第 2 类 | 21 CFR 872.5575 | 3 |
| QRQ | Non-Irrigation Endosseous Dental Implant Drill Bits | 第 1 类 | 21 CFR 872.3980 | |
| QRY | Dental Navigation System | 第 2 类 | 21 CFR 872.4120 | 5 |
| QTT | Over The Counter Electrical Salivary Stimulatory System | 第 2 类 | 21 CFR 872.5560 | 2 |
| QUA | Intraoral Cooling Device | 第 2 类 | 21 CFR 872.5590 | 2 |
| QYJ | Dental Waterline Treatment Cartridge | 第 1 类 | 21 CFR 872.6640 | 1 |
| SBC | Dental Image Analyzer | 第 2 类 | 21 CFR 872.1770 | 1 |
| SGQ | Intraoral Phototherapy Device | 第 2 类 | 21 CFR 872.5595 | 1 |
| SHI | Impression Material For Fabrication Of Patient-Matched Mouthguards, Ov | 第 2 类 | 21 CFR 872.3660 | 2 |
| SHQ | Dental Image Analyzer, In-Office | 第 2 类 | 21 CFR 872.1770 | 1 |