Imicryl Dis Malzemeleri Sanayi VE Ticaret AS: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Imicryl Dis Malzemeleri Sanayi VE Ticaret AS” (first 2019, latest 2022), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 258 days. Since 2017 the median was 258 days, against 115 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 |
|---|---|---|
| 2019 | 1 | 130 |
| 2020 | 0 | — |
| 2021 | 2 | 360 |
| 2022 | 2 | 239 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Imicryl Dis Malzemeleri Sanayi VE Ticaret AS took a median 258 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 115 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| EBF | Material, Tooth Shade, Resin | 2 | 2 |
| EMA | Cement, Dental | 2 | 2 |
| KLE | Agent, Tooth Bonding, Resin | 1 | 1 |
Review panels
- Dental (5)
Most recent Imicryl Dis Malzemeleri Sanayi VE Ticaret AS 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K220077 | IMICRYL Composite, Composite Flow Materials | EBF | 2022-08-09 | 211 |
| K213609 | NOVA RESIN dual cure, self adhesive resin cement | EMA | 2022-08-09 | 267 |
| K210473 | Nova Glass Cements (Nova Glass L, Nova Glass F, Nova Glass LC, Nova Glass BF, Nova Glass L Plus) | EMA | 2021-11-02 | 258 |
| K192913 | R&D Series Nova Compo-B Plus Bottle, R&D Series Nova Compo-B Plus Single Dose | KLE | 2021-01-19 | 462 |
| K192178 | R&D Series Nova Compo N | EBF | 2019-12-20 | 130 |
Recalls
openFDA lists no recalls under a recalling firm named Imicryl Dis Malzemeleri Sanayi VE Ticaret AS.
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.
- Imicryl Dis Malzemeleri San. VE Tic. A.S. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Imicryl Dis Malzemeleri Sanayi VE Ticaret AS?
FDA lists 5 510(k) clearances under the applicant name “Imicryl Dis Malzemeleri Sanayi VE Ticaret AS” (first 2019, latest 2022), across 3 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 Imicryl Dis Malzemeleri Sanayi VE Ticaret AS?
The median time from FDA receipt to decision across 510(k)s cleared under the name Imicryl Dis Malzemeleri Sanayi VE Ticaret AS is 258 days. Since 2017: 258 days, versus 115 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Imicryl Dis Malzemeleri Sanayi VE Ticaret AS?
The most frequent FDA product codes under this applicant name are EBF (Material, Tooth Shade, Resin, 2); EMA (Cement, Dental, 2); KLE (Agent, Tooth Bonding, Resin, 1).
Next steps
- See all 5 Imicryl Dis Malzemeleri Sanayi VE Ticaret AS clearances with predicates and recalls
- Run predicate analysis for product code EBF, Imicryl Dis Malzemeleri Sanayi VE Ticaret AS'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, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.