FDA 510(k)

DD medical polymers (PMMA)

K-Number: K230410 · 2023-06-23

Decision Date2023-06-23

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

DD medical polymers (PMMA) is a medical device manufactured by Dental Direkt GmbH. It received FDA 510(k) clearance on 2023-06-23 under approval number K230410. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DD medical polymers (PMMA)?

DD medical polymers (PMMA) is a medical device that received FDA 510(k) clearance on 2023-06-23. It is manufactured by Dental Direkt GmbH. The 510(k) number is K230410.

When was DD medical polymers (PMMA) approved by the FDA?

DD medical polymers (PMMA) received FDA 510(k) clearance on 2023-06-23, under approval number K230410.

What company makes DD medical polymers (PMMA)?

DD medical polymers (PMMA) is manufactured by Dental Direkt GmbH.

What is the FDA product code for DD medical polymers (PMMA)?

The FDA product code for DD medical polymers (PMMA) is EBI.

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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.