Subpart E—Surgical Devices
FDA submissions for Subpart E—Surgical Devices in the Dental (DE) review panel, including product codes and regulations.
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 |
