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FDA 510(k)

VITA ENAMIC STAINS

K-Number: K123761 · 2013-03-01

ApplicantInnovation Meditech GmbH
Decision Date2013-03-01
Product CodeEBD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VITA ENAMIC STAINS is the device name listed in this FDA 510(k) record. The listed applicant is Innovation Meditech GmbH. It received FDA 510(k) clearance on 2013-03-01 under 510(k) number K123761. The device is classified under product code EBD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VITA ENAMIC STAINS?

VITA ENAMIC STAINS is a medical device that received FDA 510(k) clearance on 2013-03-01. The listed applicant is Innovation Meditech GmbH. The 510(k) number is K123761.

When did VITA ENAMIC STAINS receive FDA 510(k) clearance?

VITA ENAMIC STAINS received FDA 510(k) clearance on 2013-03-01, under 510(k) number K123761.

Who is the listed applicant for VITA ENAMIC STAINS?

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

What is the FDA product code for VITA ENAMIC STAINS?

The FDA product code for VITA ENAMIC STAINS is EBD.

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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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