Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
A.B. Dental Device , Ltd. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K202144 | A.B. Dental Devices Dental Implants System | A.B. Dental Device , Ltd. | 2022-09-23 | 784 | 0 |
| K182455 | A.B. DENTAL DEVICES Dental Implants System | A.B. Dental Device , Ltd. | 2019-07-15 | 311 | 0 |
| K181381 | A.B. Dental Devices Dental Implants System | A.B. Dental Device , Ltd. | 2018-11-23 | 183 | 0 |
| K162482 | A.B. DENTAL DEVICES Dental Implants System | A.B. Dental Device , Ltd. | 2017-09-15 | 374 | 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