Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Imicryl Dis Malzemeleri Sanayi VE Ticaret AS · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
258 daysmedian FDA review time
462 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K213609 | NOVA RESIN dual cure, self adhesive resin cement | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2022-08-09 | 267 | 0 |
| K220077 | IMICRYL Composite, Composite Flow Materials | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2022-08-09 | 211 | 0 |
| K210473 | Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass L | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2021-11-02 | 258 | 0 |
| K192913 | R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2021-01-19 | 462 | 0 |
| K192178 | R&D Series Nova Compo N | Imicryl Dis Malzemeleri Sanayi VE Ticaret AS | 2019-12-20 | 130 | 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