Subpart E—Surgical Devices
FDA submissions for Subpart E—Surgical Devices in the Dental (DE) review panel, including product codes, regulations, and recent device decisions.
Section range: §§ 872.4120–872.4920
CFR Part: 872
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| DZH | Saw, Bone, Ac-Powered | 872.4120 | 2 | 4 |
| DZI | Drill, Bone, Powered | 872.4120 | 2 | 48 |
| DZJ | Driver, Wire, And Bone Drill, Manual | 872.4120 | 2 | 31 |
| KMW | Handpiece, Rotary Bone Cutting | 872.4120 | 2 | 9 |
| MXF | System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation | 872.4120 | 2 | 5 |
| PLV | Dental Stereotaxic Instrument | 872.4120 | 2 | 23 |
| QRY | Dental Navigation System | 872.4120 | 2 | 4 |
| DZA | Drill, Dental, Intraoral | 872.4130 | 1 | 13 |
| EBW | Controller, Foot, Handpiece And Cord | 872.4200 | 1 | 61 |
| EFA | Handpiece, Belt And/Or Gear Driven, Dental | 872.4200 | 1 | 25 |
| EFB | Handpiece, Air-Powered, Dental | 872.4200 | 1 | 261 |
| EGS | Handpiece, Contra- And Right-Angle Attachment, Dental | 872.4200 | 1 | 73 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 872.4200 | 1 | 89 |
| EKY | Handpiece, Water-Powered | 872.4200 | 1 | 2 |
| NYL | Handpiece, Air-Powered, Root Canal Irrigation | 872.4200 | 1 | 5 |
| EGQ | Injector, Jet, Gas-Powered | 872.4465 | 2 | 1 |
| EGM | Injector, Jet, Mechanical-Powered | 872.4475 | 2 | 11 |
| DZP | Instrument, Diamond, Dental | 872.4535 | 1 | 21 |
| NLD | Instrument, Diamond, Dental, Reprocessed | 872.4535 | 1 | 0 |
| DZN | Instruments, Dental Hand | 872.4565 | 1 | 16 |
| EAX | Mirror, Mouth | 872.4565 | 1 | 12 |
| ECB | Unit, Syringe, Air And/Or Water | 872.4565 | 1 | 12 |
| ECP | Instrument, Ligature Tucking, Orthodontic | 872.4565 | 1 | 0 |
| ECQ | Aligner, Bracket, Orthodontic | 872.4565 | 1 | 2 |
| ECR | Setter, Band, Orthodontic | 872.4565 | 1 | 3 |
| ECS | Pusher, Band, Orthodontic | 872.4565 | 1 | 2 |
| ECT | Driver, Band, Orthodontic | 872.4565 | 1 | 0 |
| EFK | Forceps, Articulation Paper | 872.4565 | 1 | 0 |
| EFL | Forceps, Dressing, Dental | 872.4565 | 1 | 5 |
| EGI | Parallelometer | 872.4565 | 1 | 1 |
| EGN | Scissors, Surgical Tissue, Dental | 872.4565 | 1 | 7 |
| EIB | Syringe, Irrigating (Dental) | 872.4565 | 1 | 4 |
| EIC | Syringe, Periodontic, Endodontic, Irrigating | 872.4565 | 1 | 16 |
| EID | Syringe, Restorative And Impression Material | 872.4565 | 1 | 13 |
| EIF | Accessories, Retractor, Dental | 872.4565 | 1 | 4 |
| EIG | Retractor, All Types | 872.4565 | 1 | 8 |
| EIK | Carver, Wax, Dental | 872.4565 | 1 | 5 |
| EIL | Gauge, Depth, Instrument, Dental | 872.4565 | 1 | 8 |
| EIR | Scissors, Collar And Crown | 872.4565 | 1 | 1 |
| EIS | Remover, Crown | 872.4565 | 1 | 19 |
| EIX | Probe, Periodontic | 872.4565 | 1 | 9 |
| EIY | Instrument, Filling, Plastic, Dental | 872.4565 | 1 | 5 |
| EJB | Handle, Instrument, Dental | 872.4565 | 1 | 8 |
| EJY | Pliers, Operative | 872.4565 | 1 | 2 |
| EJZ | Knife, Margin Finishing, Operative | 872.4565 | 1 | 2 |
| EKA | File, Margin Finishing, Operative | 872.4565 | 1 | 2 |
| EKB | Explorer, Operative | 872.4565 | 1 | 3 |
| EKC | Excavator, Dental, Operative | 872.4565 | 1 | 2 |
| EKD | Instrument, Cutting, Operative | 872.4565 | 1 | 2 |
| EKE | Curette, Operative | 872.4565 | 1 | 0 |
| EKF | Instrument, Contouring, Matrix, Operative | 872.4565 | 1 | 0 |
| EKG | Condenser, Amalgam And Foil, Operative | 872.4565 | 1 | 3 |
| EKH | Carver, Dental Amalgam, Operative | 872.4565 | 1 | 3 |
| EKI | Carrier, Amalgam, Operative | 872.4565 | 1 | 2 |
| EKJ | Burnisher, Operative | 872.4565 | 1 | 72 |
| EKK | Spreader, Pulp Canal Filling Material, Endodontic | 872.4565 | 1 | 1 |
| EKP | Reamer, Pulp Canal, Endodontic | 872.4565 | 1 | 6 |
| EKQ | Preparer, Root Canal Endodontic | 872.4565 | 1 | 2 |
| EKR | Plugger, Root Canal, Endodontic | 872.4565 | 1 | 6 |
| EKS | File, Pulp Canal, Endodontic | 872.4565 | 1 | 31 |
| EKT | Curette, Endodontic | 872.4565 | 1 | 0 |
| EKW | Broach, Endodontic | 872.4565 | 1 | 7 |
| ELA | Instrument, Hand, Calculus Removal | 872.4565 | 1 | 4 |
| EMD | Hemostat, Surgical | 872.4565 | 1 | 2 |
| EME | Punch, Biopsy, Surgical | 872.4565 | 1 | 3 |
| EMG | Forceps, Tooth Extractor, Surgical | 872.4565 | 1 | 10 |
| EMH | Forceps, Rongeur, Surgical | 872.4565 | 1 | 8 |
| EMI | File, Bone, Surgical | 872.4565 | 1 | 4 |
| EMJ | Elevator, Surgical, Dental | 872.4565 | 1 | 6 |
| EMK | Curette, Surgical, Dental | 872.4565 | 1 | 1 |
| EML | Chisel, Bone, Surgical | 872.4565 | 1 | 2 |
| EMM | Chisel, Osteotome, Surgical | 872.4565 | 1 | 4 |
| EMN | Scaler, Periodontic | 872.4565 | 1 | 5 |
| EMO | Knife, Periodontic | 872.4565 | 1 | 0 |
| EMP | Marker, Periodontic | 872.4565 | 1 | 0 |
| EMQ | Hoe, Periodontic | 872.4565 | 1 | 0 |
| EMR | File, Periodontic | 872.4565 | 1 | 1 |
| EMS | Curette, Periodontic | 872.4565 | 1 | 7 |
| JEP | Retainer, Matrix | 872.4565 | 1 | 3 |
| JEX | Plier, Orthodontic | 872.4565 | 1 | 7 |
| NYC | Dental Prophylaxis Kit | 872.4565 | 1 | 0 |
| NYF | Gingival Retraction Kit | 872.4565 | 1 | 0 |
| NYG | Lapping Tool Kit | 872.4565 | 1 | 0 |
| PWL | Oral Surgery Tray | 872.4565 | 1 | 0 |
| DYX | Lock, Wire, And Ligature, Intraoral | 872.4600 | 2 | 11 |
| EAY | Light, Fiber Optic, Dental | 872.4620 | 1 | 18 |
| EAZ | Light, Operating, Dental | 872.4630 | 1 | 23 |
| EBA | Light, Surgical Headlight | 872.4630 | 1 | 10 |
| DZM | Needle, Dental | 872.4730 | 1 | 16 |
| NMW | Needle, Dental, Reprocessed | 872.4730 | 1 | 0 |
| JEY | Plate, Bone | 872.4760 | 2 | 292 |
| MDL | Implant, Transmandibular | 872.4760 | 2 | 2 |
| MQN | External Mandibular Fixator And/Or Distractor | 872.4760 | 2 | 60 |
| NEI | Prosthesis, Condyle, Mandibular, Temporary | 872.4770 | 2 | 7 |
| ELB | Scaler, Rotary | 872.4840 | 2 | 6 |
| ELC | Scaler, Ultrasonic | 872.4850 | 2 | 195 |
| DZK | Wire, Fixation, Intraosseous | 872.4880 | 2 | 2 |
| DZL | Screw, Fixation, Intraosseous | 872.4880 | 2 | 80 |
| EKZ | Unit, Electrosurgical, And Accessories, Dental | 872.4920 | 2 | 19 |
Recent Devices
| Record | Device | Applicant | Decision Date |
|---|---|---|---|
| K252246 | Leforte MMF System | Jeil Medical Corporation | Apr 2, 2026 |
| K260773 | Varios Combi Pro2 | Nakanishi, Inc. | Mar 10, 2026 |
| K251407 | Motor Handpiece and Control Unit (SDI10) | Saeshin Precision Co., Ltd. | Jan 30, 2026 |
| K253254 | GBT Machine Airflow Prophylaxis Master | E.M.S Electro Medical Systems S.A | Jan 28, 2026 |
| K251701 | Star E900 Electric System | Dentalez, Inc., Stardental Division | Jan 12, 2026 |
| K251389 | High speed air turbine handpiece | Foshan Topmed Dental Co., Ltd. | Jan 12, 2026 |
| K251388 | Dental air-motor handpiece (TM-203B2, TM-203M4, TM-205B2, TM-205M4, TM-IS, TM-ES, TM-SG20, TM-X25, TM-BB, TM-IC, TM-RA41) | Foshan Topmed Dental Co., Ltd. | Jan 12, 2026 |
| K254163 | VarioSurg 4 | Nakanishi, Inc. | Dec 23, 2025 |
| K253373 | Southern Craniomaxillofacial (CMF) System | Southern Medical (Pty) , Ltd. | Dec 19, 2025 |
| K251441 | Inion CPS 1.5 Baby Bioabsorbable Fixation System; Inion CPS 1.5/2.0/2.5 Bioabsorbable Fixation System | Inion OY | Nov 7, 2025 |
| K252376 | Yomi S Robotic System | Neocis, Inc. | Oct 28, 2025 |
| K252223 | Alpha Endo Handpiece (Alpha Endo) | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | Oct 16, 2025 |
| K251835 | Yomi Robotic System | Neocis, Inc. | Oct 10, 2025 |
| K250123 | Master-Pin X (MP Pin with thread) (36BMP000030 / MP30) | Hager& Meisinger GmbH | Sep 29, 2025 |
| K251689 | VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) | Nakanishi, Inc. | Sep 19, 2025 |
| K251597 | InnerView System | Perimetrics, Inc. | Sep 18, 2025 |
| K251869 | Disposable Prophy Angle (3399-60, 3399-090, 3399-105) | Premium Plus (Dongguan) Limited | Sep 15, 2025 |
| K251811 | Motor and Apex Module (MaAM) | Dentsply Sirona, Inc. | Aug 25, 2025 |
| K243692 | EnDrive (EnDriveUS) | Advanced Technology Research (A.T.R.) S.R.L. | Aug 22, 2025 |
| K251569 | Bone Screw | Osstem Implant Co., Ltd. | Aug 13, 2025 |
| K243427 | QuickSleeper 5 | Dentalhitec | Aug 1, 2025 |
| K231562 | ELEC ENGINE (Model: ISE-170L) | Micro-Nx Co., Ltd. | Jul 18, 2025 |
| K243190 | USTOMED Bone Fixation/Bone Augmentation Systems - PIN | Ustomed Instrumente Ulrich Storz GmbH & Co. KG | Jun 27, 2025 |
| K240950 | Disposable Prophy Angle | Pacific Care Limited | May 28, 2025 |
| K242514 | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) | Shenzhen Rogin Medical Co., Ltd. | Apr 24, 2025 |
| K242646 | Dental Implant Unit | Guilin Aesthedent Medical Instruments Co., Ltd. | Apr 11, 2025 |
| K241065 | ChecQ (AC100) | Dentis Co., Ltd. | Mar 21, 2025 |
| K242179 | Synea Fusion Handpieces (Intensiv & Profin) | W&H Dentalwerk Bürmoos GmbH | Feb 28, 2025 |
| K243637 | Materialise Personalized Guides and Models for Craniomaxillofacial Surgery | Materialise NV | Feb 21, 2025 |
| K242317 | Integrated Endo System (Meet Endo-II) | Denjoy Dental Co., Ltd. | Feb 13, 2025 |
| K233419 | GBR System | Proimtech Saglik Urunleri Anonim Sirketi | Jan 3, 2025 |
| K243911 | HPR Cordless Hygiene Handpiece | Handpiece Headquarters | Dec 20, 2024 |
| K242263 | TECHFIT DISRP® System | Techfit Digital Surgery, Inc. | Dec 11, 2024 |
| K240337 | Dental Handpiece (Model: J6-126, J6-136, SH11W2, SH11W3, W401LW, W15LW, W142LW, W11L) | Guangdong Jinme Medical Technology Co., Ltd. | Nov 13, 2024 |
| 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. | Nov 12, 2024 |
| K240321 | MP Pin flat without thread (36BMP000020/MP20) | Hager& Meisinger GmbH | Oct 17, 2024 |
| K241880 | Air Powered Tooth Polishing System (Perio-Mate); Air Powered Tooth Polishing System (Perio Mate Nozzle Tip) | Nakanishi, Inc. | Sep 20, 2024 |
| K240183 | Star E900 Handpiece Series | Dentalez, Inc., Stardental Division | Sep 19, 2024 |
| K233721 | KLS Martin Drill-Free MMF Screw | KLS-Martin L.P. | Sep 17, 2024 |
| K242432 | MT-Bone | Mectron S.P.A. | Aug 19, 2024 |
| K241314 | KLS Martin Oral-Max Implants MR Conditional (bundled) | KLS-Martin L.P. | Aug 16, 2024 |
| K222688 | The Trust | Genoss Co., Ltd. | Aug 9, 2024 |
| K233844 | OdneClean | Odne AG | Aug 8, 2024 |
| K233563 | Navident | Claronav, Inc. | Jul 25, 2024 |
| K233865 | X-Smart Pro; X-Smart Pro+ | Dentsply Sirona, Inc. | Jul 24, 2024 |
| K240340 | Surgical Drive System (Model: ES70, ES90, E8) | Guangdong Jinme Medical Technology Co., Ltd. | Jul 18, 2024 |
| K240651 | MRI Universal | Stryker Leibinger GmbH & Co KG | Jul 12, 2024 |
| K233874 | tmCMF Solution | Techmah Cmf | Jul 11, 2024 |
| K232551 | EM-07 Cordless Endo Motor | Forum Engineering Technologies (96) , Ltd. | Jul 9, 2024 |
| K240707 | Ultrasonic Scaler (WD-JY-B002,WD-JY-W001,WD-JY-R003,WD-JY-G004,WD-JY-B003,WD-JY-C006,WD-JY-M0014, WD-JY-N0015,WD-JY-N0016,WD-JY-N0017,WD-JY-E007, WD-JY-F008,WD-JY-A005,WD-JY-H009,WD-JY-I0011, WD-JY-K0012,WD-JY-K0013,WD-JY-K0014, WD-JY-L0013,WD-JY-L0014,WD-JY-L0015, WD-JY-L0016,WD-JY-L0017) | Shenzhen Micro Electric Intelligence Co., Ltd. | Jul 2, 2024 |
| K240801 | BioSonic US200 Ultrasonic Scaler (60034537) | Dent4you AG | Jul 1, 2024 |
| K233288 | NLZ Built-In Motor System | Nakanishi, Inc. | Jun 24, 2024 |
| K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) | Nakanishi, Inc. | Jun 20, 2024 |
| K233122 | High Speed Air Turbine Handpiece (G100,G200,G300,G400,G450,G500,G600,G700,G700L,G800,G800L) | Litu Tech , Ltd. | Apr 30, 2024 |
| K232889 | METICULY Patient-specific titanium maxillofacial mesh implant | Meticuly Co., Ltd. | Apr 30, 2024 |
| K233308 | Air Motor (Model name: FX204 M4); Air Motor (Model name: M205) | Nakanishi, Inc. | Apr 25, 2024 |
| K230895 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3 L, i-XR3 L FLUO, i-XS4, | Cefla S.C. | Apr 1, 2024 |
| K233922 | SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG | Satelec - Acteon Group | Mar 11, 2024 |
| K231864 | Fiber Optic Brushless Electronic Micromotor, model: iM100 | Codent Technical Industry Co., Ltd. | Mar 11, 2024 |
| K232148 | X-Guide Surgical Navigation System | X-Nav Technologies, LLC | Feb 21, 2024 |
| K232350 | Stryker Facial iD System | Stryker Craniomaxillofacial | Jan 13, 2024 |
| K223340 | EDS Calculus Softener TURBO CR | Essential Dental Systems, Inc. | Dec 11, 2023 |
| K230641 | Ultrasonic Scaler Tips | Guilin Refine Medical Instrument Co., Ltd. | Nov 21, 2023 |
| K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoit | Micro-Nx Co., Ltd. | Nov 9, 2023 |
| K231520 | tmCMF Solution | Techmah Cmf | Oct 2, 2023 |
| K230398 | MedCAD® AccuPlate® 3DTi Patient-Specific Plating System | Medcad | Sep 26, 2023 |
| K220179 | High-Speed Air Turbine Handpieces/Straight Handpieces/Geared Angle Handpieces/Air Motors | Foshan Coxo Medical Instrument Co., Ltd. | Sep 22, 2023 |
| K232657 | InnerView LC | Perimetrics, Inc. | Sep 1, 2023 |
| K231599 | Stryker MP, Mandible, HMMF and MMF AXS Screws | Stryker Leibinger GmbH & Co KG | Aug 24, 2023 |
| K232243 | EVO 700 series high speed handpiece | Ttbio Corp. | Aug 23, 2023 |
| K231087 | Guided Surgery Kit | Implant Direct Sybron Manufacturing, LLC | Aug 16, 2023 |
| K231018 | Yomi Robotic System | Neocis, Inc. | Aug 14, 2023 |
| K230733 | Stryker Resorbable Fixation System | Stryker Leibinger GmbH & Co KG | Aug 5, 2023 |
| K223173 | Proxeo ULTRA (PB-510, PB-520 and PB-530) | W&H Dentalwerk Buermoss GmbH | Jul 14, 2023 |
| K230276 | TECHFIT DISRP® System | Techfit Digital Surgery | Jun 23, 2023 |
| K230888 | Titanium Turbine | Nakanishi, Inc. | Jun 2, 2023 |
| K230106 | General Cutting Straight | Nakanishi, Inc. | May 24, 2023 |
| K220829 | Endo Motor | Foshan Coxo Medical Instrument Co., Ltd. | May 18, 2023 |
| K231391 | Combi Touch | Mectron S.P.A. | May 15, 2023 |
| K222548 | Endo Motor | Shenzhen Perfect Medical Instruments Co., Ltd. | Apr 26, 2023 |
| K222367 | SAVE GBR | Dentis Co., Ltd. | Mar 23, 2023 |
| K222096 | Endo Ultrasonic Activator | Foshan Coxo Medical Instrument Co., Ltd. | Mar 23, 2023 |
| K223024 | MedCAD AccuPlan System | Medcad | Mar 7, 2023 |
| K221741 | TRAUS Air Dental Handpiece | Saeshin Precision Co., Ltd. | Feb 22, 2023 |
| K202674 | Medidenta High Speed Handpieces | Pac-Dent, Inc. | Dec 12, 2022 |
| K222650 | Stryker Cutomized Mandible Recon Plate; Stryker Surgeon iD Mandible Recon Plate | Stryker Craniomaxillofacial (Cmf) | Dec 9, 2022 |
| K222750 | Yomi Robotic System | Neocis, Inc. | Dec 8, 2022 |
| K211358 | Implanter incl. Accessories | Guilin Woodpecker Medical Instrument Co., Ltd. | Nov 21, 2022 |
| K222518 | FX Contra | Nakanishi, Inc. | Nov 17, 2022 |
| K212910 | Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece | Shenzhen Carejoy Technology Co., Ltd. | Nov 17, 2022 |
| K220360 | Tandry CMF Plate System | Microware Precision Co., Ltd. | Nov 10, 2022 |
| K221855 | Universal CMF System | Stryker Leibinger GmbH & Co KG | Nov 9, 2022 |
| K220874 | Smooth Drive contra angle and straight handpieces | Lares Research | Nov 7, 2022 |
| K220346 | Lotus Prophy Angle | Ajk Engineering, Inc. | Nov 7, 2022 |
| K222049 | Yomi Robotic System | Neocis, Inc. | Nov 4, 2022 |
| K220366 | EmbedMed | 3D Lifeprints UK , Ltd. | Sep 30, 2022 |
| K221548 | Dental Air Polishing Handpiece | Guilin Woodpecker Medical Instrument Co., Ltd. | Sep 28, 2022 |
| K220831 | Dental Implantation Systems, Dental Electrical Motors | Foshan Coxo Medical Instrument Co., Ltd. | Sep 27, 2022 |
| K210475 | EQ-M | Meta Systems Co., Ltd. | Sep 21, 2022 |
| K213897 | Pro M Class | Saeyang Microtech Co., Ltd. | Sep 19, 2022 |
