Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dentis Co., Ltd. — Predicate Candidate Screening
37 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
144 daysmedian FDA review time
268 days90th percentile
37clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253493 | Dentis SQ-SL AXEL Fixture | Dentis Co., Ltd. | 2026-03-04 | 128 | 0 |
| K241065 | ChecQ (AC100) | Dentis Co., Ltd. | 2025-03-21 | 337 | 0 |
| K233921 | Luvis Chair (LC700C) | Dentis Co., Ltd. | 2024-09-06 | 268 | 0 |
| K241063 | s-Clean ScanHealing Abutment | Dentis Co., Ltd. | 2024-07-25 | 98 | 0 |
| K240511 | Dentis s-Clean SQ-SL Fixture | Dentis Co., Ltd. | 2024-05-20 | 88 | 0 |
| K233544 | MESHEET | Dentis Co., Ltd. | 2024-02-22 | 111 | 0 |
| K230126 | Dentis s-Clean Regular Abutment | Dentis Co., Ltd. | 2023-08-04 | 199 | 0 |
| K230307 | Dentis i-Clean System | Dentis Co., Ltd. | 2023-07-11 | 158 | 0 |
| K230246 | Dentis s-Clean SQ-SL Narrow Implant System | Dentis Co., Ltd. | 2023-05-25 | 115 | 0 |
| K230523 | s-Clean Link Abutment Narrow | Dentis Co., Ltd. | 2023-05-24 | 86 | 0 |
| K230203 | Dentis I-FIX Abutment | Dentis Co., Ltd. | 2023-05-03 | 98 | 0 |
| K222367 | SAVE GBR | Dentis Co., Ltd. | 2023-03-23 | 230 | 0 |
| K222451 | SAVE GBR | Dentis Co., Ltd. | 2023-02-07 | 176 | 0 |
| K222913 | s-Clean Link Abutment | Dentis Co., Ltd. | 2023-01-13 | 109 | 0 |
| K222976 | MU System | Dentis Co., Ltd. | 2023-01-12 | 106 | 0 |
| K220440 | Dentis s-Clean Abutment Mini | Dentis Co., Ltd. | 2022-06-16 | 120 | 0 |
| K210410 | s-Clean Pre-Milled Abutment Mini | Dentis Co., Ltd. | 2021-09-10 | 211 | 0 |
| K210362 | s-Clean Pre-Milled Abutment | Dentis Co., Ltd. | 2021-08-19 | 192 | 0 |
| K210080 | Dentis s-Clean s-Line Mini | Dentis Co., Ltd. | 2021-06-04 | 143 | 0 |
| K210134 | Dentis s-Clean s-Line | Dentis Co., Ltd. | 2021-04-19 | 90 | 0 |
| K202773 | s-Clean SQ-SL Implant System Mini | Dentis Co., Ltd. | 2021-03-18 | 178 | 0 |
| K210132 | s-Clean SQ-SL Implant System Regular | Dentis Co., Ltd. | 2021-02-17 | 29 | 0 |
| K200099 | s-Clean SQ-SL Implant System Mini | Dentis Co., Ltd. | 2020-04-13 | 88 | 0 |
| K192688 | s-Clean SQ-SL Implant System Regular | Dentis Co., Ltd. | 2020-02-04 | 131 | 0 |
| K180657 | Resin for Temporary Crown & Bridge | Dentis Co., Ltd. | 2018-12-07 | 269 | 0 |
| K171694 | s-Clean TiN Coating Abutments | Dentis Co., Ltd. | 2017-11-29 | 175 | 0 |
| K171027 | Dentis Dental Implant System | Dentis Co., Ltd. | 2017-09-06 | 154 | 0 |
| K170220 | OneQ-SL s-Clean Implant System | Dentis Co., Ltd. | 2017-04-27 | 92 | 0 |
| K161244 | s-Clean OneQ-SL Narrow Implant System | Dentis Co., Ltd. | 2016-12-07 | 218 | 0 |
| K160213 | s-Clean Tapered II RBM Implant System | Dentis Co., Ltd. | 2016-06-21 | 144 | 0 |
| K153639 | OneQ-SL s-Clean Implant System | Dentis Co., Ltd. | 2016-04-08 | 109 | 0 |
| K142313 | OneQ-SL Implant System | Dentis Co., Ltd. | 2015-12-10 | 478 | 0 |
| K150344 | Dentis Dental Implant System | Dentis Co., Ltd. | 2015-07-24 | 163 | 0 |
| K111364 | HAPTITE COATING IMPLANT SYSTEM | Dentis Co., Ltd. | 2012-02-01 | 261 | 0 |
| K082843 | MODIFICATON TO: DENTIS DENTAL IMPLANT SYSTEM | Dentis Co., Ltd. | 2009-06-19 | 263 | 0 |
| K083586 | I-FIX SYSTEM | Dentis Co., Ltd. | 2009-04-29 | 146 | 0 |
| K073486 | DENTIS DENTAL IMPLANT SYSTEM | Dentis Co., Ltd. | 2008-04-04 | 114 | 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