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)

CEREC SpeedGlaze

K-Number: K160099 · 2016-06-02

ApplicantSirona Dental Systems GmbH
Decision Date2016-06-02
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CEREC SpeedGlaze is a medical device manufactured by Sirona Dental Systems GmbH. It received FDA 510(k) clearance on 2016-06-02 under approval number K160099. 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 CEREC SpeedGlaze?

CEREC SpeedGlaze is a medical device that received FDA 510(k) clearance on 2016-06-02. It is manufactured by Sirona Dental Systems GmbH. The 510(k) number is K160099.

When was CEREC SpeedGlaze approved by the FDA?

CEREC SpeedGlaze received FDA 510(k) clearance on 2016-06-02, under approval number K160099.

What company makes CEREC SpeedGlaze?

CEREC SpeedGlaze is manufactured by Sirona Dental Systems GmbH.

What is the FDA product code for CEREC SpeedGlaze?

The FDA product code for CEREC SpeedGlaze 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.

↑