Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dentium Co., Ltd. — Predicate Candidate Screening
22 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
178 daysmedian FDA review time
279 days90th percentile
22clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213599 | SuperLine | Dentium Co., Ltd. | 2022-02-23 | 100 | 0 |
| K193341 | iCTmotor (WL-1) | Dentium Co., Ltd. | 2020-09-04 | 276 | 0 |
| K192436 | Healing Abutments and Cover Screws | Dentium Co., Ltd. | 2020-01-23 | 139 | 0 |
| K191634 | Scan Abutments and Comfort Caps | Dentium Co., Ltd. | 2019-11-04 | 138 | 0 |
| K172640 | Dentium Implantium & SuperLine Prosthetics | Dentium Co., Ltd. | 2018-05-14 | 255 | 0 |
| K171622 | Dentium Ti-Base | Dentium Co., Ltd. | 2018-01-11 | 223 | 0 |
| K171126 | Implantium II | Dentium Co., Ltd. | 2017-09-07 | 143 | 0 |
| K170384 | Dentium NR Line CAD/CAM Abutments | Dentium Co., Ltd. | 2017-08-17 | 191 | 0 |
| K160965 | SuperLine | Dentium Co., Ltd. | 2017-01-13 | 282 | 0 |
| K161713 | Dentium CAD/CAM Abutments | Dentium Co., Ltd. | 2016-12-16 | 178 | 0 |
| K160828 | Dentium Implantium & SuperLine Prosthetics | Dentium Co., Ltd. | 2016-09-15 | 174 | 0 |
| K160483 | Burn-out Cylinder and Angled Screw Abutments | Dentium Co., Ltd. | 2016-08-05 | 165 | 0 |
| K153268 | NR Line Implant System | Dentium Co., Ltd. | 2016-07-20 | 251 | 0 |
| K141457 | DENTIUM IMPLANTIUM AND SUPERLINE ABUTMENTS | Dentium Co., Ltd. | 2014-11-12 | 163 | 0 |
| K112045 | SIMPLELINE II ABUTMENT SYSTEM | Dentium Co., Ltd. | 2012-01-26 | 192 | 0 |
| K111162 | SLIM ONEBODY SYSTEM | Dentium Co., Ltd. | 2012-01-13 | 263 | 0 |
| K102308 | SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS | Dentium Co., Ltd. | 2010-11-22 | 98 | 0 |
| K070228 | IMPLANTIUM PROSTHETICS | Dentium Co., Ltd. | 2007-11-20 | 300 | 0 |
| K052957 | IMPLANTIUM PROSTHETICS | Dentium Co., Ltd. | 2006-07-27 | 279 | 0 |
| K060501 | IMPLANTIUM II | Dentium Co., Ltd. | 2006-06-16 | 112 | 0 |
| K060500 | SPEEDY ORTHODONTIC SCREW | Dentium Co., Ltd. | 2006-06-16 | 112 | 0 |
| K041368 | DENTIUM CO., LTD. IMPLANTIUM | Dentium Co., Ltd. | 2004-07-29 | 66 | 1 |
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