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)

DD Contrast

K-Number: K193588 · 2020-04-16

ApplicantDental Direkt GmbH
Decision Date2020-04-16
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

DD Contrast is a medical device manufactured by Dental Direkt GmbH. It received FDA 510(k) clearance on 2020-04-16 under approval number K193588. 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 DD Contrast?

DD Contrast is a medical device that received FDA 510(k) clearance on 2020-04-16. It is manufactured by Dental Direkt GmbH. The 510(k) number is K193588.

When was DD Contrast approved by the FDA?

DD Contrast received FDA 510(k) clearance on 2020-04-16, under approval number K193588.

What company makes DD Contrast?

DD Contrast is manufactured by Dental Direkt GmbH.

What is the FDA product code for DD Contrast?

The FDA product code for DD Contrast is EIH.

Other Devices by Dental Direkt GmbH

K153490DD medical polymers K170885DD cubeX2 HS K183569DD cube ONE ML K230410DD medical polymers (PMMA) K230218DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series) K191111DD Solid Connect® CAD/CAM Abutments

View all 8 devices →

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.

↑