Materialise Dental NV FDA Record
Materialise Dental NV has 0 FDA recalls, 0 inspections, 5 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Materialise Dental NV" is on file.
- Latest 510(k)
- Jul 5, 2012
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 5 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K120733 | SIMPLANT GO | Jul 5, 2012 |
| K113739 | SIMPLANT IMMEDIATE SMILE DENTAL CARE SYSTEM | May 30, 2012 |
| K112679 | SIMPLANT NAVIGATOR PERSONALIZED DENTAL CARE SYSTEM | Feb 22, 2012 |
| K110300 | SIMPLANT 2011 | Jul 1, 2011 |
| K081402 | SIMPLANT ORTHO ; VISTADENT 3D | Jul 18, 2008 |
Materialise Dental NV and the FDA: common questions
Has Materialise Dental NV received an FDA warning letter?
No FDA warning letter addressed to the name "Materialise Dental NV" is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Materialise Dental NV received an FDA Form 483?
FDA has not published a Form 483 for "Materialise Dental NV" in its reading room. FDA publishes some Form 483s, not all of them.
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