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FDA 510(k)

priti multidisc ZrO2 High Translucent

K-Number: K161025 · 2017-02-03

ApplicantPritidenta GmbH
Decision Date2017-02-03
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

priti multidisc ZrO2 High Translucent is the device name listed in this FDA 510(k) record. The listed applicant is Pritidenta GmbH. It received FDA 510(k) clearance on 2017-02-03 under 510(k) number K161025. The device is classified under product code EIH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the priti multidisc ZrO2 High Translucent?

priti multidisc ZrO2 High Translucent is a medical device that received FDA 510(k) clearance on 2017-02-03. The listed applicant is Pritidenta GmbH. The 510(k) number is K161025.

When did priti multidisc ZrO2 High Translucent receive FDA 510(k) clearance?

priti multidisc ZrO2 High Translucent received FDA 510(k) clearance on 2017-02-03, under 510(k) number K161025.

Who is the listed applicant for priti multidisc ZrO2 High Translucent?

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

What is the FDA product code for priti multidisc ZrO2 High Translucent?

The FDA product code for priti multidisc ZrO2 High Translucent is EIH.

Related Devices (Code: EIH)

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.

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