Company · US
Dentsply Sirona
FDA 510(k) clearances and medical device recalls filed under this name, 2016 to 2026. Name variants (Inc, Corp, punctuation) are merged.
89510(k) clearances (12 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NHA | Abutment, Implant, Dental, Endosseous | 23 |
| DZE | Implant, Endosseous, Root-Form | 9 |
| EBI | Resin, Denture, Relining, Repairing, Rebasing | 6 |
| KCT | Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | 6 |
| EIH | Powder, Porcelain | 5 |
| LLZ | System, Image Processing, Radiological | 3 |
| NDP | Accessories, Implant, Dental, Endosseous | 3 |
| NXC | Aligner, Sequential | 3 |
| OAS | X-Ray, Tomography, Computed, Dental | 3 |
| QIH | Automated Radiological Image Processing Software | 3 |
| EBF | Material, Tooth Shade, Resin | 2 |
| EBW | Controller, Foot, Handpiece And Cord | 2 |
| EKX | Handpiece, Direct Drive, Ac-Powered | 2 |
| EMA | Cement, Dental | 2 |
| EZD | Catheter, Straight | 2 |
| GEX | Powered Laser Surgical Instrument | 2 |
| KNT | Tubes, Gastrointestinal (And Accessories) | 2 |
| MYN | Analyzer, Medical Image | 2 |
| PNN | Orthodontic Software | 2 |
| EBZ | Activator, Ultraviolet, For Polymerization | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 30, 2026 | K261072 | DS Core Detect Dentsply Sirona, Inc. | MYN |
| Sep 4, 2026 | K261935 | Surgical and Prosthetic Trays Dentsply Sirona, Inc. | KCT |
| Aug 21, 2026 | K262127 | DS Core CBCT Anatomy Dentsply Sirona | QIH |
| Apr 23, 2026 | K260785 | DS Core CBCT Anatomy Dentsply Sirona | QIH |
| Apr 15, 2026 | K260722 | SureSmile Aligner (ASSY500020) Dentsply Sirona, Inc. | NXC |
| Mar 4, 2026 | K253565 | SureSmile Software Dentsply Sirona, Inc. | PNN |
| Feb 6, 2026 | K251614 | Stainless Steel Surgical Kits Dentsply Sirona, Inc. | KCT |
| Feb 5, 2026 | K253959 | Primevision 3D Dentsply Sirona | OAS |
| Jan 7, 2026 | K253009 | DS Core Detect Dentsply Sirona, Inc. | MYN |
| Dec 9, 2025 | K252343 | Atlantis® Abutments in Titanium Dentsply Sirona | NHA |
| Nov 26, 2025 | K252248 | CEREC Tessera Abutment System Dentsply Sirona | NHA |
| Nov 21, 2025 | K251205 | Atlantis® Abutments in Titanium for Straumann BLX and Neodent GM Implants Dentsply Sirona | NHA |
| Aug 29, 2025 | K250771 | Primescan 2 Dentsply Sirona, Inc. | NTK |
| Aug 25, 2025 | K251811 | Motor and Apex Module (MaAM) Dentsply Sirona, Inc. | EBW |
| Aug 21, 2025 | K251647 | MIS C1 Implant System, MIS Seven Implant System, MIS M4 Implant System, MIS Lance+ Implant System, MIS Lance+ Conical Co Dentsply Sirona, Inc. | DZE |
| Aug 12, 2025 | K250755 | DS Core Diagnosis Dentsply Sirona, Inc. | QIH |
| Jul 24, 2025 | K251297 | MIS LYNX Conical Connection Implant System Dentsply Sirona, Inc. | DZE |
| Jul 22, 2025 | K251300 | Plastic Surgical Kits Dentsply Sirona, Inc. | KCT |
| Apr 30, 2025 | K250295 | Dentsply Sirona Titanium Bases system Dentsply Sirona | NHA |
| Apr 11, 2025 | K250081 | Atlantis® Abutments in Titanium Dentsply Sirona | NHA |
| Feb 13, 2025 | K243546 | AH Plus Endodontic Sealer Dentsply Sirona, Inc. | KIF |
| Dec 17, 2024 | K243336 | Lucitone Digital Print Denture System Dentsply Sirona, Inc. | EBI |
| Nov 25, 2024 | K241692 | MIS LYNX Conical Connection Implant System Dentsply Sirona, Inc. | DZE |
| Oct 24, 2024 | K242462 | CEREC Cercon 4D CAD/CAM Blocks Dentsply Sirona | EIH |
| Aug 28, 2024 | K241557 | Cercon® yo ML Dentsply Sirona | EIH |
| Jul 24, 2024 | K233865 | X-Smart Pro; X-Smart Pro+ Dentsply Sirona, Inc. | EKX |
| May 7, 2024 | K234018 | CEREC Cercon 4D Abutment Blocks, CEREC Cercon 4D Abutment System Dentsply Sirona | NHA |
| Apr 2, 2024 | K240888 | Calibra Abutment Resin Cement Dentsply Sirona | EMA |
| Jan 16, 2024 | K231144 | Washtrays Dentsply Sirona | KCT |
| Oct 20, 2023 | K231578 | Lucitone Digital Print Denture System Dentsply Sirona | EBI |
| Oct 18, 2023 | K230199 | Byte Aligner System Dentsply Sirona, Inc. | NXC |
| May 4, 2023 | K223756 | SimPro Now, GentleCath Hydrophilic Dentsply Sirona | EZD |
| Mar 22, 2023 | K221402 | CEREC Tessera Abutment Block, CEREC Tessera Abutment System Dentsply Sirona, Inc. | NHA |
| Nov 16, 2022 | K221094 | OmniTaper EV Dental Implants, DS Implants abutments with EV connection Dentsply Sirona | DZE |
| Nov 16, 2022 | K220841 | PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments with EV connection (XS) Dentsply Sirona | DZE |
| May 3, 2022 | K220791 | Surgical and Prosthetic Trays Dentsply Sirona | KCT |
| Apr 1, 2022 | K213432 | MIS Angulated multi-unit abutments Dentsply Sirona | NHA |
| Mar 4, 2022 | K212281 | Surgical Trays Dentsply Sirona, Inc. | KCT |
| Feb 17, 2022 | K211212 | LoFric Elle Dentsply Sirona | EZD |
| Nov 15, 2021 | K213449 | DS Implants abutments provided with the EV connection Dentsply Sirona | NHA |
| Aug 27, 2021 | K210610 | PrimeTaper EV Dental Implant Dentsply Sirona, Inc. | DZE |
| Jul 28, 2021 | K211225 | MIS Ti-base abutment Dentsply Sirona | NHA |
| Jun 17, 2021 | K210886 | MIS Lance+ Conical Connection Dental Implant System Dentsply Sirona | DZE |
| Jan 20, 2021 | K202629 | Dentsply Sirona Universal Spray Glazes Dentsply Sirona | EIH |
| Sep 3, 2020 | K200102 | MIS Dental Implant System Dentsply Sirona | DZE |
| Sep 2, 2020 | K193405 | Simplant Digital Guide Dentsply Sirona | NDP |
| Aug 19, 2020 | K200191 | Sirona Dental CAD/CAM System with InLab Software Dentsply Sirona | PNP |
| Aug 16, 2020 | K193408 | Sirona Dental CAD/CAM System with CEREC Chairside Software Dentsply Sirona | NHA |
| Jul 6, 2020 | K191152 | MIS Ti-base Abutment Dentsply Sirona | NHA |
| Jun 22, 2020 | K201140 | Axeos Dentsply Sirona | OAS |
Newest 50 of 89.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||