FDA 510(k)

PEEK Biosolution

K-Number: K173124 · 2017-12-18

Decision Date2017-12-18

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

PEEK Biosolution is a medical device manufactured by Merz Dental GmbH. It received FDA 510(k) clearance on 2017-12-18 under approval number K173124. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PEEK Biosolution?

PEEK Biosolution is a medical device that received FDA 510(k) clearance on 2017-12-18. It is manufactured by Merz Dental GmbH. The 510(k) number is K173124.

When was PEEK Biosolution approved by the FDA?

PEEK Biosolution received FDA 510(k) clearance on 2017-12-18, under approval number K173124.

What company makes PEEK Biosolution?

PEEK Biosolution is manufactured by Merz Dental GmbH.

What is the FDA product code for PEEK Biosolution?

The FDA product code for PEEK Biosolution is EBF.

Related Devices (Code: EBF)

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Official Source

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