Noris Medical , Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Noris Medical , Ltd.” (first 2014, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 267 days. Since 2017 the median was 264 days, against 191 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2014 | 1 | 301 |
| 2015 | 0 | — |
| 2016 | 2 | 222 |
| 2017 | 1 | 212 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 410 |
| 2023 | 0 | — |
| 2024 | 1 | 133 |
| 2025 | 1 | 264 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Noris Medical , Ltd. took a median 264 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 191 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DZE | Implant, Endosseous, Root-Form | 7 | 7 |
| NHA | Abutment, Implant, Dental, Endosseous | 1 | 1 |
Review panels
- Dental (8)
Most recent Noris Medical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K241462 | LONGY Implant and LONGY-N Implant | DZE | 2025-02-11 | 264 |
| K240202 | Conical Platform Dental Implants System | DZE | 2024-06-06 | 133 |
| K210852 | Noris Medical Dental Implants System - Cortical | DZE | 2022-06-24 | 459 |
| K210356 | Noris Medical Dental Implants System | NHA | 2022-02-04 | 361 |
| K162308 | Noris Medical MBI-2mm Dental Implant System | DZE | 2017-03-17 | 212 |
| K153043 | Noris Medical MBI Dental Implant System | DZE | 2016-04-11 | 175 |
| K151909 | Noris Medical Zygomatic Dental Implant System | DZE | 2016-04-08 | 270 |
| K140440 | NORIS MEDICAL DENTAL IMPLANTS SYSTEM | DZE | 2014-12-19 | 301 |
Recalls
openFDA lists no recalls under a recalling firm named Noris Medical , Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Noris Medical , Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Noris Medical , Ltd.” (first 2014, latest 2025), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Noris Medical , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Noris Medical , Ltd. is 267 days. Since 2017: 264 days, versus 191 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Noris Medical , Ltd.?
The most frequent FDA product codes under this applicant name are DZE (Implant, Endosseous, Root-Form, 7); NHA (Abutment, Implant, Dental, Endosseous, 1).
Next steps
- See all 8 Noris Medical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code DZE, Noris Medical , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.