Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Noris Medical , Ltd. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
270 daysmedian FDA review time
459 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241462 | LONGY Implant and LONGY-N Implant | Noris Medical , Ltd. | 2025-02-11 | 264 | 0 |
| K240202 | Conical Platform Dental Implants System | Noris Medical , Ltd. | 2024-06-06 | 133 | 0 |
| K210852 | Noris Medical Dental Implants System - Cortical | Noris Medical , Ltd. | 2022-06-24 | 459 | 0 |
| K210356 | Noris Medical Dental Implants System | Noris Medical , Ltd. | 2022-02-04 | 361 | 0 |
| K162308 | Noris Medical MBI-2mm Dental Implant System | Noris Medical , Ltd. | 2017-03-17 | 212 | 0 |
| K153043 | Noris Medical MBI Dental Implant System | Noris Medical , Ltd. | 2016-04-11 | 175 | 0 |
| K151909 | Noris Medical Zygomatic Dental Implant System | Noris Medical , Ltd. | 2016-04-08 | 270 | 0 |
| K140440 | NORIS MEDICAL DENTAL IMPLANTS SYSTEM | Noris Medical , Ltd. | 2014-12-19 | 301 | 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