Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Jdentalcare Srl — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
267 daysmedian FDA review time
694 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K251148 | JDEvolution Plus L and JDEvolution Plus LE | Jdentalcare Srl | 2025-09-25 | 164 | 0 |
| K240143 | JDZygoma dental implants | Jdentalcare Srl | 2024-10-11 | 267 | 0 |
| K233896 | JDentalCare Dental Implant System: JDEvolution; JDEvolution | Jdentalcare Srl | 2024-08-16 | 249 | 0 |
| K182081 | JDentalCare Implant System JDIcon | Jdentalcare Srl | 2020-06-26 | 694 | 0 |
| K143142 | JDENTALCARE Implant System | Jdentalcare Srl | 2015-11-06 | 368 | 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