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FDA 510(k)

VITA LUMEX AC

K-Number: K193434 · 2020-07-21

Decision Date2020-07-21
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VITA LUMEX AC is a medical device manufactured by Vita Zahnfabrik GmbH H Rauter & CO. It received FDA 510(k) clearance on 2020-07-21 under approval 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. It is manufactured by Vita Zahnfabrik GmbH H Rauter & CO. The 510(k) number is K193434.

When was VITA LUMEX AC approved by the FDA?

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

What company makes VITA LUMEX AC?

VITA LUMEX AC is manufactured by Vita Zahnfabrik GmbH H Rauter & CO.

What is the FDA product code for VITA LUMEX AC?

The FDA product code for VITA LUMEX AC is EIH.

Other Devices by Vita Zahnfabrik GmbH H Rauter & CO

Related Devices (Code: EIH)

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.