Panels › Dental
Dental devices
281 product codes reviewed by the Dental panel. 12,700 510(k) clearances and 1,349 recalls in the FDA data, 62% of those recalls name a 510(k).
222510(k)s in 12 months
32recalls in 12 months
832recalls that name a 510(k)
Active product codes, Class II
| Code | Device | Class | 510(k)s, 12 mo | Recalls, 12 mo |
|---|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 2 | 30 | 5 |
| DZE | Implant, Endosseous, Root-Form | 2 | 19 | 2 |
| EBF | Material, Tooth Shade, Resin | 2 | 18 | 2 |
| EIH | Powder, Porcelain | 2 | 17 | 1 |
| LRK | Device, Anti-Snoring | 2 | 13 | 2 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | 10 | 0 |
| EMA | Cement, Dental | 2 | 10 | 0 |
| KLE | Agent, Tooth Bonding, Resin | 2 | 8 | 0 |
| KIF | Resin, Root Canal Filling | 2 | 7 | 0 |
| LBH | Varnish, Cavity | 2 | 7 | 0 |
| PNN | Orthodontic Software | 2 | 7 | 0 |
| EHD | Unit, X-Ray, Extraoral With Timer | 2 | 6 | 0 |
| NXC | Aligner, Sequential | 2 | 6 | 0 |
| JEY | Plate, Bone | 2 | 4 | 0 |
| NPL | Barrier, Animal Source, Intraoral | 2 | 4 | 0 |
| SHI | Impression Material For Fabrication Of Patient-Matched Mouthguards, Over-The-Counter | 2 | 4 | 0 |
| DYH | Adhesive, Bracket And Tooth Conditioner, Resin | 2 | 3 | 0 |
| DZI | Drill, Bone, Powered | 2 | 3 | 0 |
| ELW | Material, Impression | 2 | 3 | 0 |
| LYC | Bone Grafting Material, Synthetic | 2 | 3 | 0 |
| NPM | Bone Grafting Material, Animal Source | 2 | 3 | 0 |
| DZJ | Driver, Wire, And Bone Drill, Manual | 2 | 2 | 0 |
| EBG | Crown And Bridge, Temporary, Resin | 2 | 2 | 0 |
| EJK | Liner, Cavity, Calcium Hydroxide | 2 | 2 | 0 |
| ELC | Scaler, Ultrasonic | 2 | 2 | 0 |
| MUH | System, X-Ray, Extraoral Source, Digital | 2 | 2 | 0 |
| PLC | Sleep Appliances With Patient Monitoring | 2 | 2 | 0 |
| QRY | Dental Navigation System | 2 | 2 | 0 |
| DYW | Bracket, Plastic, Orthodontic | 2 | 1 | 0 |
| DZL | Screw, Fixation, Intraosseous | 2 | 1 | 0 |
| EBC | Sealant, Pit And Fissure, And Conditioner | 2 | 1 | 0 |
| EBD | Coating, Filling Material, Resin | 2 | 1 | 0 |
| EBZ | Activator, Ultraviolet, For Polymerization | 2 | 1 | 0 |
| NBL | Light-Induced Fluorescence Caries Detector | 2 | 1 | 0 |
| NTK | Light Transmission Caries Detector | 2 | 1 | 0 |
| OAT | Implant, Endosseous, Orthodontic | 2 | 1 | 0 |
| POW | Crown And Bridge, Long-Term Temporary, Resin | 2 | 1 | 0 |
| SGQ | Intraoral Phototherapy Device | 2 | 1 | 0 |
| SHQ | Dental Image Analyzer, In-Office | 2 | 1 | 0 |
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