FDA 510(k)

E-Denture Pro

K-Number: K203641 · 2021-03-30

Decision Date2021-03-30

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

E-Denture Pro is the device name listed in this FDA 510(k) record. The listed applicant is Envisiontec GmbH. It received FDA 510(k) clearance on 2021-03-30 under 510(k) number K203641. 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 E-Denture Pro?

E-Denture Pro is a medical device that received FDA 510(k) clearance on 2021-03-30. The listed applicant is Envisiontec GmbH. The 510(k) number is K203641.

When did E-Denture Pro receive FDA 510(k) clearance?

E-Denture Pro received FDA 510(k) clearance on 2021-03-30, under 510(k) number K203641.

Who is the listed applicant for E-Denture Pro?

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

What is the FDA product code for E-Denture Pro?

The FDA product code for E-Denture Pro is EBI.

Other records listing Envisiontec GmbH 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.

K220894SmileGuard K211101E-Temp K210977E-Dent 1000 K201173E-Guard

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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.