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Dental devices
281 product codes reviewed by the Dental panel. 12,694 510(k) clearances and 1,349 recalls in the FDA data, 62% of those recalls name a 510(k).
223510(k)s in 12 months
32recalls in 12 months
832recalls that name a 510(k)
Codes with the most recalls
| Code | Device | All time | 12 months |
|---|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 225 | 5 |
| DZE | Implant, Endosseous, Root-Form | 212 | 2 |
| JEY | Plate, Bone | 111 | 0 |
| EBF | Material, Tooth Shade, Resin | 71 | 2 |
| NDP | Accessories, Implant, Dental, Endosseous | 57 | 1 |
| JEQ | Toothbrush, Powered | 36 | 2 |
| EIH | Powder, Porcelain | 35 | 1 |
| LTF | Stimulator, Salivary System | 35 | 0 |
| DZI | Drill, Bone, Powered | 21 | 0 |
| OFX | General Purpose Dental Tray | 21 | 5 |
| KLE | Agent, Tooth Bonding, Resin | 20 | 0 |
| LZD | Joint, Temporomandibular, Implant | 20 | 2 |
| EHD | Unit, X-Ray, Extraoral With Timer | 18 | 0 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 16 | 0 |
| EMA | Cement, Dental | 16 | 0 |
Active product codes
| 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 | 20 | 2 |
| EBF | Material, Tooth Shade, Resin | 2 | 19 | 2 |
| EIH | Powder, Porcelain | 2 | 15 | 1 |
| LRK | Device, Anti-Snoring | 2 | 14 | 2 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 2 | 10 | 0 |
| EMA | Cement, Dental | 2 | 10 | 0 |
| KLE | Agent, Tooth Bonding, Resin | 2 | 9 | 0 |
| KIF | Resin, Root Canal Filling | 2 | 7 | 0 |
| PNN | Orthodontic Software | 2 | 7 | 0 |
| EHD | Unit, X-Ray, Extraoral With Timer | 2 | 6 | 0 |
| LBH | Varnish, Cavity | 2 | 6 | 0 |
| NXC | Aligner, Sequential | 2 | 6 | 0 |
| JEY | Plate, Bone | 2 | 5 | 0 |
| NSB | Patient Personal Hygiene Kit | 1 | 0 | 5 |
| OFX | General Purpose Dental Tray | 1 | 0 | 5 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 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 |
| EBW | Controller, Foot, Handpiece And Cord | 1 | 3 | 0 |
| ELW | Material, Impression | 2 | 3 | 0 |
| LYC | Bone Grafting Material, Synthetic | 2 | 3 | 0 |
| MUH | System, X-Ray, Extraoral Source, Digital | 2 | 3 | 0 |
| NPL | Barrier, Animal Source, Intraoral | 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 |
| EIA | Unit, Operative Dental | 1 | 2 | 0 |
| EJK | Liner, Cavity, Calcium Hydroxide | 2 | 2 | 0 |
| ELC | Scaler, Ultrasonic | 2 | 2 | 0 |
| JEQ | Toothbrush, Powered | 1 | 0 | 2 |
| LZD | Joint, Temporomandibular, Implant | 3 | 0 | 2 |
| 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 |
| EFD | Amalgamator, Dental, Ac-Powered | 1 | 0 | 1 |
| EFW | Toothbrush, Manual | 1 | 0 | 1 |
| EHJ | Disk, Abrasive | 1 | 0 | 1 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 1 | 1 | 0 |
| NBL | Light-Induced Fluorescence Caries Detector | 2 | 1 | 0 |
| NDP | Accessories, Implant, Dental, Endosseous | 1 | 0 | 1 |
| NQA | Biologic Material, Dental | 3 | 0 | 1 |
| 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 |
| QJJ | Indirect Bonding Tray | 1 | 0 | 1 |
| SGQ | Intraoral Phototherapy Device | 2 | 1 | 0 |
| SHQ | Dental Image Analyzer, In-Office | 2 | 1 | 0 |
| SJH | Portable Dental Operative Unit | 1 | 1 | 0 |
Latest recalls in this panel
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 15, 2026 | Straumann USA LLC GM Helix Implant, REF: 109.984; Open, Classified |
DZE | K163194 |
| Sep 3, 2026 | Cardinal Health 200, LLC Presource Packs Containing CliniClean Pericare Wipes within BD Urinary Catheter Trays:
1) KIT,MAXILLOFACIAL PRESBYTERIAN, Catalog Number: PWV2MF01D Open, Classified |
OFX | None listed |
| Aug 31, 2026 | Medline Industries, LP Medline Convenience Kits containing BD ChloraPrep Clear - 1mL Applicators
PATIENT ADMIN KIT
DYKA1384B
DYKA1384C
WELCOME KIT
DYKS1206D Open, Classified |
NSB | None listed |
| Aug 25, 2026 | Henry Schein Inc. Grandio Universal Nano-Hybrid Restorative Material - Capsules 0.25Gm, Product Codes:
1) 949-3594, Mfr Product Code 1840; Lots 2529604, 2538147, 2608145
2) 949-3595, Mfr Product Code 1841; Lots 25390 Open, Classified |
EBF | K051867 |
| Aug 25, 2026 | Henry Schein Inc. Structur 2 SC Temporary Resin Cartridge Refill 75Gm, Product Codes:
1) 114-3933, Mfr Product Code 1479; Lots 2536179, 2606429
2) 114-3934, Mfr Product Code 1480; Lot 2539064
3) 114-3935, Mfr Produc Open, Classified |
EBF | K040769 |
| Aug 14, 2026 | SDI Limited Dentsply Sirona Capsule Mixer
Model No. 5546068 Open, Classified |
EFD | None listed |
| Aug 11, 2026 | Straumann USA LLC Straumann Bone Level Tapered (BLT) Implant, D 4.1mm RC, SLActive 14mm, Roxolid, Loxim (Article 021.5314); implant, endosseous, root-form Open, Classified |
DZE | K140878 |
| Aug 10, 2026 | Straumann USA LLC GM Helix Implant, Endosseous Dental Implant
Article No. 109.984 Open, Classified |
NHA | K163194 |
| Jul 21, 2026 | Prismatik Dentalcraft, Inc. Brand Name: Silent Nite
Product Name: Silent Nite Sleep Appliance
Model/Catalog Number: SILNT
Product Description: Silent Nite Sleep Appliance is a mandibular advancement device (MAD) intended to t Open, Classified |
LRK | K183270 K972424 |
| Jul 15, 2026 | Papablic Inc Papablic Replacement Brush Heads. Model Number: PAPA317AA. Open, Classified |
JEQ | None listed |
| Jul 15, 2026 | Papablic Inc Papablic Replacement Brush Heads. Model Number: Papablic18B Open, Classified |
JEQ | None listed |
| Jul 8, 2026 | Klowen Braces KL Owen Custom Orthodontic Solution, model/catalog number CIAS-800033, Open, Classified |
QJJ | None listed |
| Jun 22, 2026 | TMJ Solutions Inc TMJ Bilateral Implants, REF: CHG020 Open, Classified |
LZD | None listed |
| Jun 17, 2026 | Medline Industries, LP MEDLINE Medical Procedure Kits labeled as: NURSING KIT, Medline Kit Number/SKU EDUC1044 Open, Classified |
NSB | None listed |
| Jun 17, 2026 | Medline Industries, LP MEDLINE Medical Procedure Kits labeled as: ORAL RESTORATION, Medline Kit Number/SKUDYNJ86253A Open, Classified |
OFX | None listed |
| Jun 9, 2026 | Sagemax Bioceramics, Inc. NexxZr T Multi A3.5 W98-16mm, REF: 745451 Open, Classified |
EIH | K142233 |
| May 7, 2026 | Medline Industries, LP Medline Convenience Kits:
1) ADMIT KIT, Model Number: DYKA1343A Open, Classified |
NSB | None listed |
| May 7, 2026 | Medline Industries, LP Medline Convenience Kits:
1) DYNDA3003, Model Number: DENTAL PACK;
2) DYNJ87157, Model Number: GULLO SURGICAL PACK Open, Classified |
OFX | None listed |
| Apr 30, 2026 | Medline Industries, LP Medline medical procedure kits, containing Medline Neuro Sponges, labeled as follows:
1. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920D;
2. RR-OMFS PACK-LF, Medline Kit Number/SKU DYNJ0045920 Open, Classified |
OFX | None listed |
| Apr 29, 2026 | Straumann USA LLC Straumann n!ce Zr, HT, Full-arch Restoration. Article 010.0158.
Endosseous Dental Implant Abutments Open, Classified |
NHA | K222836 |
| Apr 29, 2026 | Straumann USA LLC Straumann n!ce PMMA Full-arch Restoration. Screw-retained Bridge. Article 010.0304.
Endosseous Dental Implant Abutments Open, Classified |
NHA | K242686 |
| Mar 27, 2026 | Ultradent Products, Inc. Jiffy Original Composite Polisher Cups (Coarse) 12pk, REF 7011. Open, Classified |
EHJ | None listed |
| Mar 24, 2026 | Straumann USA LLC Custom Abutment AS Ti, for Straumann RC, incl. TAN screw;
Catalog Number/Art.: 010.5438; Open, Classified |
NHA | K243278 |
| Mar 24, 2026 | Straumann USA LLC Custom Abutment Ti, for Straumann RC, incl. TAN screw;
Catalog Number/Art.: 027.4620; Open, Classified |
NHA | K072151 |
| Feb 17, 2026 | Medline Industries, LP Medline Convenience Kits:
1) ADMIT KIT, Model Number: DYKA1343A Open, Classified |
NSB | None listed |
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