Materialise Dental NV: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Materialise Dental NV” (first 2008, latest 2012), across 1 product code in 1 review panel. Median 510(k) review time under this name: 149 days. 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 |
|---|---|---|
| 2012 | 3 | 161 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 5 | 5 |
Review panels
- Radiology (5)
Most recent Materialise Dental NV 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120733 | SIMPLANT GO | LLZ | 2012-07-05 | 118 |
| K113739 | SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM | LLZ | 2012-05-30 | 162 |
| K112679 | SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM | LLZ | 2012-02-22 | 161 |
| K110300 | SIMPLANT 2011 | LLZ | 2011-07-01 | 149 |
| K081402 | SIMPLANT ORTHO ; VISTADENT 3D | LLZ | 2008-07-18 | 60 |
Recalls
openFDA lists no recalls under a recalling firm named Materialise Dental NV.
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Materialise NV (61 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Materialise Dental NV?
FDA lists 5 510(k) clearances under the applicant name “Materialise Dental NV” (first 2008, latest 2012), across 1 product code 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 Materialise Dental NV?
The median time from FDA receipt to decision across 510(k)s cleared under the name Materialise Dental NV is 149 days.
Which FDA product codes appear under Materialise Dental NV?
The most frequent FDA product codes under this applicant name are LLZ (System, Image Processing, Radiological, 5).
Next steps
- See all 5 Materialise Dental NV clearances with predicates and recalls
- Run predicate analysis for product code LLZ, Materialise Dental NV'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.