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FDA 510(k)

VITA Ambria

K-Number: K193436 · 2020-05-14

Decision Date2020-05-14
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VITA Ambria is a medical device manufactured by Vita Zahnfabrik GmbH H Rauter & CO. It received FDA 510(k) clearance on 2020-05-14 under approval number K193436. 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 Ambria?

VITA Ambria is a medical device that received FDA 510(k) clearance on 2020-05-14. It is manufactured by Vita Zahnfabrik GmbH H Rauter & CO. The 510(k) number is K193436.

When was VITA Ambria approved by the FDA?

VITA Ambria received FDA 510(k) clearance on 2020-05-14, under approval number K193436.

What company makes VITA Ambria?

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

What is the FDA product code for VITA Ambria?

The FDA product code for VITA Ambria 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.