FDA applicant

Imicryl Dis Malzemeleri Sanayi VE Ticaret AS

Konya, TR5 decisions2019–20220 recalls

FDA records 5 decisions for Imicryl Dis Malzemeleri Sanayi VE Ticaret AS (Konya, TR) from 2019 to 2022: 5 510(k) clearances. Most are in product codes EMA (Cement, Dental) and EBF (Material, Tooth Shade, Resin). Since 2016 its 510(k)s took a median of 258 days from receipt to decision, against 163 for FDA’s reviews in the same codes and years. Its devices cite 6 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Imicryl Dis Malzemeleri Sanayi VE Ticaret AS’s devices, and how often a recall has named them.

FDA decisions per year

2in 2022

2019high 2 (2021) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2019.

FIG. 1 — Imicryl Dis Malzemeleri Sanayi VE Ticaret AS by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Imicryl”

FDA records each applicant name separately; these may or may not be the same firm.

Imicryl Dis Malzemeleri San. VE Tic. A.S. 1

Imicryl Dis Malzemeleri Sanayi VE Ticaret AS

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

What has FDA decided for it lately?

Other applicant names beginning “Imicryl”