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)

Luminesse Shaded Zirconia SZ

K-Number: K152023 · 2016-09-15

ApplicantTalladium, Inc.
Decision Date2016-09-15
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Luminesse Shaded Zirconia SZ is a medical device manufactured by Talladium, Inc.. It received FDA 510(k) clearance on 2016-09-15 under approval number K152023. 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 Luminesse Shaded Zirconia SZ?

Luminesse Shaded Zirconia SZ is a medical device that received FDA 510(k) clearance on 2016-09-15. It is manufactured by Talladium, Inc.. The 510(k) number is K152023.

When was Luminesse Shaded Zirconia SZ approved by the FDA?

Luminesse Shaded Zirconia SZ received FDA 510(k) clearance on 2016-09-15, under approval number K152023.

What company makes Luminesse Shaded Zirconia SZ?

Luminesse Shaded Zirconia SZ is manufactured by Talladium, Inc..

What is the FDA product code for Luminesse Shaded Zirconia SZ?

The FDA product code for Luminesse Shaded Zirconia SZ 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 K153130Initial LiSi BlockGC America, Inc. K160867Pavati Z40.2 ZirconiaCcri, 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.

↑