Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Dentsply Sirona · Predicate Candidate Screening
65 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
129 daysmedian FDA review time
259 days90th percentile
65clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260785 | DS Core CBCT Anatomy | Dentsply Sirona | 2026-04-23 | 44 | 0 |
| K253959 | Primevision 3D | Dentsply Sirona | 2026-02-05 | 57 | 0 |
| K252343 | Atlantis® Abutments in Titanium | Dentsply Sirona | 2025-12-09 | 134 | 0 |
| K252248 | CEREC Tessera Abutment System | Dentsply Sirona | 2025-11-26 | 131 | 0 |
| K251205 | Atlantis® Abutments in Titanium for Straumann BLX and Neoden | Dentsply Sirona | 2025-11-21 | 217 | 0 |
| K250295 | Dentsply Sirona Titanium Bases system | Dentsply Sirona | 2025-04-30 | 89 | 0 |
| K250081 | Atlantis® Abutments in Titanium | Dentsply Sirona | 2025-04-11 | 88 | 0 |
| K242462 | CEREC Cercon 4D CAD/CAM Blocks | Dentsply Sirona | 2024-10-24 | 66 | 0 |
| K241557 | Cercon® yo ML | Dentsply Sirona | 2024-08-28 | 89 | 0 |
| K234018 | CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment | Dentsply Sirona | 2024-05-07 | 139 | 0 |
| K240888 | Calibra Abutment Resin Cement | Dentsply Sirona | 2024-04-02 | 1 | 0 |
| K231144 | Washtrays | Dentsply Sirona | 2024-01-16 | 270 | 0 |
| K231578 | Lucitone Digital Print Denture System | Dentsply Sirona | 2023-10-20 | 142 | 0 |
| K223756 | SimPro™ Now, GentleCath™ Hydrophilic | Dentsply Sirona | 2023-05-04 | 140 | 0 |
| K220841 | PrimeTaper EV Dental Implants Ø3.0, DS Implants abutments wi | Dentsply Sirona | 2022-11-16 | 238 | 0 |
| K221094 | OmniTaper EV Dental Implants, DS Implants abutments with EV | Dentsply Sirona | 2022-11-16 | 216 | 0 |
| K220791 | Surgical and Prosthetic Trays | Dentsply Sirona | 2022-05-03 | 46 | 0 |
| K213432 | MIS Angulated multi-unit abutments | Dentsply Sirona | 2022-04-01 | 161 | 0 |
| K211212 | LoFric Elle | Dentsply Sirona | 2022-02-17 | 300 | 0 |
| K213449 | DS Implants abutments provided with the EV connection | Dentsply Sirona | 2021-11-15 | 20 | 0 |
| K211225 | MIS Ti-base abutment | Dentsply Sirona | 2021-07-28 | 96 | 0 |
| K210886 | MIS Lance+ Conical Connection Dental Implant System | Dentsply Sirona | 2021-06-17 | 84 | 0 |
| K202629 | Dentsply Sirona Universal Spray Glazes | Dentsply Sirona | 2021-01-20 | 131 | 0 |
| K200102 | MIS Dental Implant System | Dentsply Sirona | 2020-09-03 | 230 | 0 |
| K193405 | Simplant Digital Guide | Dentsply Sirona | 2020-09-02 | 268 | 0 |
| K200191 | Sirona Dental CAD/CAM System with InLab Software | Dentsply Sirona | 2020-08-19 | 205 | 0 |
| K193408 | Sirona Dental CAD/CAM System with CEREC Chairside Software | Dentsply Sirona | 2020-08-16 | 251 | 0 |
| K191152 | MIS Ti-base Abutment | Dentsply Sirona | 2020-07-06 | 432 | 0 |
| K201140 | Axeos | Dentsply Sirona | 2020-06-22 | 54 | 0 |
| K193078 | MIS CONNECT Conical Connection System | Dentsply Sirona | 2020-03-25 | 141 | 0 |
| K193529 | ATLANTIS Abutment for MIS Conical Connection Implants | Dentsply Sirona | 2020-03-05 | 76 | 0 |
| K192530 | Surefil one Self-adhesive Composite Hybrid | Dentsply Sirona | 2020-01-23 | 129 | 0 |
| K192409 | Midwest Rhino XE and Air Motor M | Dentsply Sirona | 2020-01-13 | 131 | 0 |
| K190977 | Navina Smart System, Navina Classic System | Dentsply Sirona | 2019-11-22 | 221 | 0 |
| K191865 | SmartLite Pro Modular LED Curing Light | Dentsply Sirona | 2019-11-20 | 131 | 0 |
| K191806 | Propex IQ Apex Locator | Dentsply Sirona | 2019-10-03 | 90 | 0 |
| K190059 | CEREC Guides | Dentsply Sirona | 2019-09-27 | 259 | 0 |
| K191427 | Halley resin system | Dentsply Sirona | 2019-08-26 | 89 | 0 |
| K191616 | Orthophos S | Dentsply Sirona | 2019-07-16 | 28 | 0 |
| K190043 | Halley resin | Dentsply Sirona | 2019-04-24 | 105 | 0 |
| K182422 | Lucitone Denture Base Materials | Dentsply Sirona | 2018-12-18 | 103 | 0 |
| K182288 | TPH Spectra ST Flowable Composite Restorative | Dentsply Sirona | 2018-11-20 | 89 | 0 |
| K181520 | Sirona Dental CAD/CAM System | Dentsply Sirona | 2018-10-11 | 122 | 0 |
| K181476 | Prime&Bond active Universal Adhesive | Dentsply Sirona | 2018-09-28 | 115 | 0 |
| K181189 | ATLANTIS Conus Structure | Dentsply Sirona | 2018-07-18 | 76 | 0 |
| K172239 | SIMPLANT 18 | Dentsply Sirona | 2018-04-04 | 252 | 0 |
| K180044 | SIROLaser Blue | Dentsply Sirona | 2018-03-08 | 59 | 0 |
| K171122 | CEREC Ortho Software | Dentsply Sirona | 2018-01-11 | 269 | 0 |
| K172225 | Atlantis Abutment for MIS Implant | Dentsply Sirona | 2017-11-30 | 128 | 0 |
| K170487 | Navina Classic System | Dentsply Sirona | 2017-09-11 | 206 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda