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)

ATLANTIS Crown

K-Number: K152247 · 2016-01-29

ApplicantDentsply International, Inc.
Decision Date2016-01-29
Product CodeEIH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ATLANTIS Crown is a medical device manufactured by Dentsply International, Inc.. It received FDA 510(k) clearance on 2016-01-29 under approval number K152247. 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 ATLANTIS Crown?

ATLANTIS Crown is a medical device that received FDA 510(k) clearance on 2016-01-29. It is manufactured by Dentsply International, Inc.. The 510(k) number is K152247.

When was ATLANTIS Crown approved by the FDA?

ATLANTIS Crown received FDA 510(k) clearance on 2016-01-29, under approval number K152247.

What company makes ATLANTIS Crown?

ATLANTIS Crown is manufactured by Dentsply International, Inc..

What is the FDA product code for ATLANTIS Crown?

The FDA product code for ATLANTIS Crown is EIH.

Other Devices by Dentsply International, Inc.

K160207ATLANTIS ISUS Implant Suprastructures K160232Disposable Barrier Sleeves and Covers K151439ATLANTIS ISUS K151039ATLANTIS Abutment for NobelActive 3.0

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.

↑