Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dentsply Sirona, Inc. — Predicate Candidate Screening
21 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
124 daysmedian FDA review time
255 days90th percentile
21clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260722 | SureSmile Aligner (ASSY500020) | Dentsply Sirona, Inc. | 2026-04-15 | 41 | 0 |
| K253565 | SureSmile Software | Dentsply Sirona, Inc. | 2026-03-04 | 107 | 0 |
| K251614 | Stainless Steel Surgical Kits | Dentsply Sirona, Inc. | 2026-02-06 | 255 | 0 |
| K253009 | DS Core Detect | Dentsply Sirona, Inc. | 2026-01-07 | 110 | 0 |
| K250771 | Primescan 2 | Dentsply Sirona, Inc. | 2025-08-29 | 169 | 0 |
| K251811 | Motor and Apex Module (MaAM) | Dentsply Sirona, Inc. | 2025-08-25 | 74 | 0 |
| K251647 | MIS C1 Implant System, MIS Seven Implant System, MIS M4 Impl | Dentsply Sirona, Inc. | 2025-08-21 | 84 | 0 |
| K250755 | DS Core Diagnosis | Dentsply Sirona, Inc. | 2025-08-12 | 153 | 0 |
| K251297 | MIS LYNX Conical Connection Implant System | Dentsply Sirona, Inc. | 2025-07-24 | 87 | 0 |
| K251300 | Plastic Surgical Kits | Dentsply Sirona, Inc. | 2025-07-22 | 85 | 0 |
| K243546 | AH Plus Endodontic Sealer | Dentsply Sirona, Inc. | 2025-02-13 | 90 | 0 |
| K243336 | Lucitone Digital Print Denture™ System | Dentsply Sirona, Inc. | 2024-12-17 | 54 | 0 |
| K241692 | MIS LYNX Conical Connection Implant System | Dentsply Sirona, Inc. | 2024-11-25 | 166 | 0 |
| K233865 | X-Smart Pro; X-Smart Pro+ | Dentsply Sirona, Inc. | 2024-07-24 | 231 | 0 |
| K230199 | Byte Aligner System | Dentsply Sirona, Inc. | 2023-10-18 | 266 | 1 |
| K221402 | CEREC Tessera Abutment Block, CEREC Tessera Abutment System | Dentsply Sirona, Inc. | 2023-03-22 | 310 | 0 |
| K212281 | Surgical Trays | Dentsply Sirona, Inc. | 2022-03-04 | 226 | 0 |
| K210610 | PrimeTaper EV Dental Implant | Dentsply Sirona, Inc. | 2021-08-27 | 179 | 0 |
| K193064 | Atlantis suprastructures | Dentsply Sirona, Inc. | 2020-03-03 | 120 | 0 |
| K192149 | MIS Dental Implant System | Dentsply Sirona, Inc. | 2019-12-11 | 124 | 0 |
| K183079 | Conometric Abutments | Dentsply Sirona, Inc. | 2019-07-10 | 247 | 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