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FDA 510(k)

Freeprint denture

K-Number: K200461 · 2020-11-16

ApplicantDetax GmbH & Co. KG
Decision Date2020-11-16
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Freeprint denture is a medical device manufactured by Detax GmbH & Co. KG. It received FDA 510(k) clearance on 2020-11-16 under approval 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. It is manufactured by Detax GmbH & Co. KG. The 510(k) number is K200461.

When was Freeprint denture approved by the FDA?

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

What company makes Freeprint denture?

Freeprint denture is manufactured by Detax GmbH & Co. KG.

What is the FDA product code for Freeprint denture?

The FDA product code for Freeprint denture is EBI.

Other Devices by Detax GmbH & Co. KG

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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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