Subpart D—Prosthetic Devices
FDA submissions for Subpart D—Prosthetic Devices in the Dental (DE) review panel, including product codes and regulations.
Section range: §§ 872.3060–872.3980
CFR Part: 872
Product Codes
| Product Code | Device Name | Regulation | Class | Devices |
|---|---|---|---|---|
| EIT | Applicator, Rapid Wax, Dental | 872.3060 | 2 | 1 |
| EJS | Alloy, Other Noble Metal | 872.3060 | 2 | 194 |
| EJT | Alloy, Gold-Based Noble Metal | 872.3060 | 2 | 627 |
| EJJ | Alloy, Amalgam | 872.3070 | 2 | 74 |
| ELY | Mercury | 872.3070 | 2 | 4 |
| OIV | Dental Amalgam | 872.3070 | 2 | 3 |
| EHE | Dispenser, Mercury And/Or Alloy | 872.3080 | 1 | 2 |
| EFD | Amalgamator, Dental, Ac-Powered | 872.3100 | 1 | 15 |
| DZS | Capsule, Dental, Amalgam | 872.3110 | 1 | 4 |
| EJX | Anchor, Preformed | 872.3130 | 1 | 1 |
| KXR | Applicator, Resin | 872.3140 | 1 | 3 |
| EJP | Articulators | 872.3150 | 1 | 11 |
| KZO | Ink, Arch Tracing | 872.3150 | 1 | 2 |
| EGG | Attachment, Precision, All | 872.3165 | 1 | 24 |
| EHO | Bar, Preformed | 872.3165 | 1 | 3 |
| KLE | Agent, Tooth Bonding, Resin | 872.3200 | 2 | 418 |
| KCR | Facebow | 872.3220 | 1 | 1 |
| EJL | Bur, Dental | 872.3240 | 1 | 27 |
| NME | Bur, Diamond Coated, Reprocessed | 872.3240 | 1 | 0 |
| EJK | Liner, Cavity, Calcium Hydroxide | 872.3250 | 2 | 77 |
| LBH | Varnish, Cavity | 872.3260 | 2 | 135 |
| PHR | Diammine Silver Fluoride Dental Hypersensitivity Varnish | 872.3260 | 2 | 8 |
| PME | External Cleaning Solution | 872.3260 | 2 | 3 |
| EMA | Cement, Dental | 872.3275 | 2 | 504 |
| EMB | Zinc Oxide Eugenol | 872.3275 | 1 | 11 |
| MZW | Dental Cement W/Out Zinc-Oxide Eugenol As An Ulcer Covering For Pain Relief | 872.3275 | 2 | 2 |
| NEA | Cement, Ear, Nose And Throat | 872.3275 | 2 | 6 |
| EHP | Clasp, Preformed | 872.3285 | 1 | 8 |
| EJW | Clasp, Wire | 872.3285 | 1 | 3 |
| EBE | Coating, Denture Hydrophilic, Resin | 872.3300 | 2 | 3 |
| EBD | Coating, Filling Material, Resin | 872.3310 | 2 | 52 |
| ELZ | Crown, Preformed | 872.3330 | 1 | 9 |
| ELO | Cusp, Gold And Stainless Steel | 872.3350 | 1 | 0 |
| EHQ | Cusp, Preformed | 872.3360 | 1 | 0 |
| KOM | Adhesive, Denture, Acacia And Karaya With Sodium Borate | 872.3400 | 1 | 1 |
| KOR | Adhesive, Denture, Karaya With Sodium Borate | 872.3400 | 3 | 0 |
| MMU | Adhesive, Denture, Acacia And Karaya With Sodium Borate > 12% By Weight | 872.3400 | 3 | 0 |
| KOL | Adhesive, Denture, Carboxymethylcellulose Sodium (32%) And Ethylene-Oxide Homopolymer | 872.3410 | 1 | 2 |
| KOQ | Adhesive, Denture, Carboxymethylcellulose Sodium (40-100&) | 872.3410 | 1 | 4 |
| KXW | Adhesive, Denture, Carboxymethylcellulose Sodium (49%) And Ethylene-Oxide Homopolymer | 872.3410 | 1 | 0 |
| KOS | Adhesive, Denture, Carboxymethylcellulose Sodium And Cationic Polyacrylamide Polymer | 872.3420 | 3 | 0 |
| KOP | Adhesive, Denture, Karaya | 872.3450 | 1 | 1 |
| KXX | Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer | 872.3450 | 1 | 1 |
| KON | Adhesive, Denture, Polyacrylamide Polymer (Modified Cationic) | 872.3480 | 3 | 0 |
| KOO | Adhesive, Denture, Polyvinyl Methylether Maleic Acid Calcium-Sodium Double Salt | 872.3490 | 1 | 4 |
| KOT | Carboxymethylcellulose Sodium Or Polyvinyl Methylether Maleic Acid Calcium-Sodium | 872.3490 | 1 | 8 |
| KXY | Polyvinyl Methylether Maleic Anhydride &/Or Acid Copolymer & Carboxymethylce | 872.3500 | 3 | 0 |
| EFT | Cleanser, Denture, Over The Counter | 872.3520 | 1 | 26 |
| NUX | Cleanser, Denture, Prescription | 872.3520 | 1 | 0 |
| JER | Cleaner, Denture, Mechanical | 872.3530 | 1 | 14 |
| EHR | Pad, Denture, Over The Counter | 872.3540 | 2 | 0 |
| EHS | Cushion, Denture, Over The Counter | 872.3540 | 2 | 3 |
| NKJ | Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter | 872.3540 | 1 | 0 |
| EBP | Reliner, Denture, Over The Counter | 872.3560 | 2 | 3 |
| EBO | Denture Repair Kit | 872.3570 | 2 | 7 |
| ELN | Teeth, Preformed Gold Denture | 872.3580 | 1 | 1 |
| ELM | Denture, Plastic, Teeth | 872.3590 | 2 | 55 |
| PZY | Additively Manufactured, Preformed, Resin Denture Tooth | 872.3590 | 2 | 1 |
| EKO | Denture Preformed (Partially Prefabricated Denture) | 872.3600 | 2 | 4 |
| NHA | Abutment, Implant, Dental, Endosseous | 872.3630 | 2 | 702 |
| PNP | Dental Abutment Design Software For Dental Laboratory | 872.3630 | 2 | 8 |
| DZE | Implant, Endosseous, Root-Form | 872.3640 | 2 | 1543 |
| NRQ | Blade-Form Endosseous Dental Implant | 872.3640 | 2 | 5 |
| OAT | Implant, Endosseous, Orthodontic | 872.3640 | 2 | 51 |
| ELE | Implant, Subperiosteal | 872.3645 | 2 | 4 |
| ELW | Material, Impression | 872.3660 | 2 | 402 |
| SHI | Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter | 872.3660 | 2 | 2 |
| KZN | Scanner, Color | 872.3661 | 2 | 2 |
| NOF | System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations | 872.3661 | 2 | 5 |
| QJK | Intraoral Camera | 872.3661 | 2 | 0 |
| EBH | Material, Impression Tray, Resin | 872.3670 | 1 | 30 |
| NFE | Materials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Alveolar Ridge Augmentation | 872.3680 | 2 | 0 |
| EBF | Material, Tooth Shade, Resin | 872.3690 | 2 | 924 |
| OFW | Restorative Instrument And Component Tray | 872.3690 | 2 | 0 |
| EJH | Alloy, Metal, Base | 872.3710 | 2 | 153 |
| KCS | Pantograph | 872.3730 | 1 | 0 |
| EBL | Pin, Retentive And Splinting, And Accessory Instruments | 872.3740 | 1 | 11 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 872.3750 | 2 | 192 |
| KZP | Solution, Cement Dissolving | 872.3750 | 2 | 2 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 872.3760 | 2 | 328 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 872.3765 | 2 | 130 |
| EBG | Crown And Bridge, Temporary, Resin | 872.3770 | 2 | 189 |
| POW | Crown And Bridge, Long-Term Temporary, Resin | 872.3770 | 2 | 1 |
| ELR | Post, Root Canal | 872.3810 | 1 | 35 |
| KIF | Resin, Root Canal Filling | 872.3820 | 2 | 143 |
| MMT | Resin, Root Canal Filling Containing Chloroform | 872.3820 | 3 | 0 |
| NYD | Endodontic Kit | 872.3820 | 2 | 0 |
| EKN | Point, Paper, Endodontic | 872.3830 | 1 | 7 |
| EKL | Point, Silver, Endodontic | 872.3840 | 1 | 3 |
| EKM | Gutta-Percha | 872.3850 | 1 | 23 |
| ELS | Splint, Endodontic Stabilizing | 872.3890 | 2 | 6 |
| ELJ | Teeth, Artificial, Posterior With Metal Insert | 872.3900 | 1 | 0 |
| ELK | Teeth, Artificial, Backing And Facing | 872.3910 | 1 | 2 |
| ELL | Teeth, Porcelain | 872.3920 | 2 | 39 |
| LYC | Bone Grafting Material, Synthetic | 872.3930 | 2 | 229 |
| NPK | Barrier, Synthetic, Intraoral | 872.3930 | 2 | 31 |
| NPL | Barrier, Animal Source, Intraoral | 872.3930 | 2 | 57 |
| NPM | Bone Grafting Material, Animal Source | 872.3930 | 2 | 39 |
| NPZ | Bone Grafting Material, Dental, With Biologic Component | 872.3930 | 3 | 3 |
| NQA | Biologic Material, Dental | 872.3930 | 3 | 1 |
| NUN | Bone Grafting Material, Human Source | 872.3930 | 2 | 15 |
| LZD | Joint, Temporomandibular, Implant | 872.3940 | 3 | 3 |
| MPI | Glenoid Fossa Prosthesis | 872.3950 | 3 | 1 |
| MPL | Mandibular Condyle Prosthesis | 872.3960 | 3 | 0 |
| MPJ | Interarticular Disc Prosthesis (Interpositional Implant) | 872.3970 | 3 | 0 |
| NDP | Accessories, Implant, Dental, Endosseous | 872.3980 | 1 | 4 |
| NYE | Fixture Mount Kit | 872.3980 | 1 | 0 |
| OFY | Dental Implant Surgical Tray | 872.3980 | 1 | 0 |
| QRQ | Non-Irrigation Endosseous Dental Implant Drill Bits | 872.3980 | 1 | 0 |
