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FDA 510(k)

VITA LUMEX AC

K-Number: K193434 · 2020-07-21

ApplicantVita Zahnfabrik GmbH H Rauter & CO
Decision Date2020-07-21
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VITA LUMEX AC is the device name listed in this FDA 510(k) record. The listed applicant is Vita Zahnfabrik GmbH H Rauter & CO. It received FDA 510(k) clearance on 2020-07-21 under 510(k) number K193434. 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 VITA LUMEX AC?

VITA LUMEX AC is a medical device that received FDA 510(k) clearance on 2020-07-21. The listed applicant is Vita Zahnfabrik GmbH H Rauter & CO. The 510(k) number is K193434.

When did VITA LUMEX AC receive FDA 510(k) clearance?

VITA LUMEX AC received FDA 510(k) clearance on 2020-07-21, under 510(k) number K193434.

Who is the listed applicant for VITA LUMEX AC?

The FDA 510(k) record lists Vita Zahnfabrik GmbH H Rauter & CO as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VITA LUMEX AC?

The FDA product code for VITA LUMEX AC is EIH.

Other records listing Vita Zahnfabrik GmbH H Rauter & CO 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.

K211854VITA Akzent LCK193436VITA Ambria

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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