Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Z-CAD smile

K-Number: K170050 · 2018-08-23

ApplicantMetoxit AG
Decision Date2018-08-23
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Z-CAD smile is a medical device manufactured by Metoxit AG. It received FDA 510(k) clearance on 2018-08-23 under approval number K170050. 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 Z-CAD smile?

Z-CAD smile is a medical device that received FDA 510(k) clearance on 2018-08-23. It is manufactured by Metoxit AG. The 510(k) number is K170050.

When was Z-CAD smile approved by the FDA?

Z-CAD smile received FDA 510(k) clearance on 2018-08-23, under approval number K170050.

What company makes Z-CAD smile?

Z-CAD smile is manufactured by Metoxit AG.

What is the FDA product code for Z-CAD smile?

The FDA product code for Z-CAD smile is EIH.

Related Devices (Code: EIH)

K162677L- OVCRhondium, Ltd. K160079rainbow ShineGenoss Co., Ltd. K160203ADAMANT ZIRCONIA DISCAdamant Co., Ltd. K160262n!ce LT Glass Ceramic Blocks, n!ce HT Glass Ceramic Blocks,Institut Straumann AG K152023Luminesse Shaded Zirconia SZTalladium, Inc. K153130Initial LiSi BlockGC America, Inc.

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.

↑