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FDA 510(k)

X-cera Zirconia Blanks

K-Number: K153767 · 2016-03-29

ApplicantShenzhen Xiangtong Photoelectricity Technology Co., Ltd.
Decision Date2016-03-29
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

X-cera Zirconia Blanks is a medical device manufactured by Shenzhen Xiangtong Photoelectricity Technology Co., Ltd.. It received FDA 510(k) clearance on 2016-03-29 under approval number K153767. 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 X-cera Zirconia Blanks?

X-cera Zirconia Blanks is a medical device that received FDA 510(k) clearance on 2016-03-29. It is manufactured by Shenzhen Xiangtong Photoelectricity Technology Co., Ltd.. The 510(k) number is K153767.

When was X-cera Zirconia Blanks approved by the FDA?

X-cera Zirconia Blanks received FDA 510(k) clearance on 2016-03-29, under approval number K153767.

What company makes X-cera Zirconia Blanks?

X-cera Zirconia Blanks is manufactured by Shenzhen Xiangtong Photoelectricity Technology Co., Ltd..

What is the FDA product code for X-cera Zirconia Blanks?

The FDA product code for X-cera Zirconia Blanks 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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