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FDA 510(k)

ZIRCONIA BLANKS (ZIRCOSTAR)

K-Number: K120852 · 2012-06-06

ApplicantKerox, Ltd.
Decision Date2012-06-06
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ZIRCONIA BLANKS (ZIRCOSTAR) is the device name listed in this FDA 510(k) record. The listed applicant is Kerox, Ltd.. It received FDA 510(k) clearance on 2012-06-06 under 510(k) number K120852. 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 ZIRCONIA BLANKS (ZIRCOSTAR)?

ZIRCONIA BLANKS (ZIRCOSTAR) is a medical device that received FDA 510(k) clearance on 2012-06-06. The listed applicant is Kerox, Ltd.. The 510(k) number is K120852.

When did ZIRCONIA BLANKS (ZIRCOSTAR) receive FDA 510(k) clearance?

ZIRCONIA BLANKS (ZIRCOSTAR) received FDA 510(k) clearance on 2012-06-06, under 510(k) number K120852.

Who is the listed applicant for ZIRCONIA BLANKS (ZIRCOSTAR)?

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

What is the FDA product code for ZIRCONIA BLANKS (ZIRCOSTAR)?

The FDA product code for ZIRCONIA BLANKS (ZIRCOSTAR) is EIH.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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