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FDA 510(k)

IMICRYL Impression Materials

K-Number: K213890 · 2022-02-11

ApplicantImicryl Dis Malzemeleri San. VE Tic. A.S.
Decision Date2022-02-11
Product CodeELW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

IMICRYL Impression Materials is a medical device manufactured by Imicryl Dis Malzemeleri San. VE Tic. A.S.. It received FDA 510(k) clearance on 2022-02-11 under approval number K213890. The device is classified under product code ELW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMICRYL Impression Materials?

IMICRYL Impression Materials is a medical device that received FDA 510(k) clearance on 2022-02-11. It is manufactured by Imicryl Dis Malzemeleri San. VE Tic. A.S.. The 510(k) number is K213890.

When was IMICRYL Impression Materials approved by the FDA?

IMICRYL Impression Materials received FDA 510(k) clearance on 2022-02-11, under approval number K213890.

What company makes IMICRYL Impression Materials?

IMICRYL Impression Materials is manufactured by Imicryl Dis Malzemeleri San. VE Tic. A.S..

What is the FDA product code for IMICRYL Impression Materials?

The FDA product code for IMICRYL Impression Materials is ELW.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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