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FDA 510(k)

Eclipse Kiss Zirconia

K-Number: K163238 · 2017-05-04

ApplicantAms
Decision Date2017-05-04
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Eclipse Kiss Zirconia is a medical device manufactured by Ams. It received FDA 510(k) clearance on 2017-05-04 under approval number K163238. 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 Eclipse Kiss Zirconia?

Eclipse Kiss Zirconia is a medical device that received FDA 510(k) clearance on 2017-05-04. It is manufactured by Ams. The 510(k) number is K163238.

When was Eclipse Kiss Zirconia approved by the FDA?

Eclipse Kiss Zirconia received FDA 510(k) clearance on 2017-05-04, under approval number K163238.

What company makes Eclipse Kiss Zirconia?

Eclipse Kiss Zirconia is manufactured by Ams.

What is the FDA product code for Eclipse Kiss Zirconia?

The FDA product code for Eclipse Kiss Zirconia 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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