Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Creodent Prosthetics, Ltd. — Predicate Candidate Screening
9 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
220 daysmedian FDA review time
637 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220390 | CreoDent Solidex Customized Abutment and Screw | Creodent Prosthetics, Ltd. | 2022-12-02 | 294 | 0 |
| K211427 | CREOKORREKT Aligners | Creodent Prosthetics, Ltd. | 2022-10-13 | 524 | 0 |
| K202909 | CreoDent Solidex Customized Abutment | Creodent Prosthetics, Ltd. | 2021-04-02 | 185 | 0 |
| K202095 | CreoDent Solidex Customized Abutment and Screw | Creodent Prosthetics, Ltd. | 2020-12-16 | 140 | 0 |
| K170100 | CreoDent Solidex Customized Abutment and Screw | Creodent Prosthetics, Ltd. | 2017-07-18 | 188 | 0 |
| K162734 | CreoDent Solidex Customized Abutment | Creodent Prosthetics, Ltd. | 2017-05-08 | 220 | 0 |
| K160436 | CreoDent Solidex Custom Abutment | Creodent Prosthetics, Ltd. | 2016-09-29 | 225 | 0 |
| K150012 | CreoDent Solidex Customized Abutment | Creodent Prosthetics, Ltd. | 2015-06-04 | 150 | 0 |
| K113738 | CREODENT SOLIDEX CUSTOM ABUTMENT | Creodent Prosthetics, Ltd. | 2013-09-17 | 637 | 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