FDA 510(k)

Freeprint denture

K-Number: K200461 · 2020-11-16

Decision Date2020-11-16

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

Freeprint denture is the device name listed in this FDA 510(k) record. The listed applicant is Detax GmbH & Co. KG. It received FDA 510(k) clearance on 2020-11-16 under 510(k) number K200461. 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 Freeprint denture?

Freeprint denture is a medical device that received FDA 510(k) clearance on 2020-11-16. The listed applicant is Detax GmbH & Co. KG. The 510(k) number is K200461.

When did Freeprint denture receive FDA 510(k) clearance?

Freeprint denture received FDA 510(k) clearance on 2020-11-16, under 510(k) number K200461.

Who is the listed applicant for Freeprint denture?

The FDA 510(k) record lists Detax GmbH & Co. KG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Freeprint denture?

The FDA product code for Freeprint denture is EBI.

Other records listing Detax GmbH & Co. KG as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.