Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vertex-Dental B.V. · Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
161 daysmedian FDA review time
288 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K241071 | NextDent Jet Denture Base; NextDent Jet Denture Teeth | Vertex-Dental B.V. | 2024-09-04 | 138 | 0 |
| K231388 | NextDent Base | Vertex-Dental B.V. | 2023-10-20 | 161 | 0 |
| K221022 | NextDent Ortho Flex | Vertex-Dental B.V. | 2022-10-21 | 198 | 0 |
| K191497 | NextDent Denture 3D+ | Vertex-Dental B.V. | 2019-11-01 | 149 | 0 |
| K162572 | NextDent Denture, E-Denture | Vertex-Dental B.V. | 2017-06-30 | 288 | 0 |
| K123220 | VERTEX THERMOSENS RIGID | Vertex-Dental B.V. | 2013-03-01 | 137 | 0 |
| K102640 | VERTEX SELF CURING, VERTEX CASTAVARIA, VERTEX CASTAPRESS | Vertex-Dental B.V. | 2011-03-25 | 192 | 0 |
| K102654 | VERTEX RAPID SIMPLIFIED | Vertex-Dental B.V. | 2010-12-03 | 80 | 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