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)

ClearMet

K-Number: K152051 · 2016-03-22

Decision Date2016-03-22
Product CodeEBI
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ClearMet is a medical device manufactured by Mycone Dental Supply Co., T/A Keystone Industries. It received FDA 510(k) clearance on 2016-03-22 under approval number K152051. The device is classified under product code EBI. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearMet?

ClearMet is a medical device that received FDA 510(k) clearance on 2016-03-22. It is manufactured by Mycone Dental Supply Co., T/A Keystone Industries. The 510(k) number is K152051.

When was ClearMet approved by the FDA?

ClearMet received FDA 510(k) clearance on 2016-03-22, under approval number K152051.

What company makes ClearMet?

ClearMet is manufactured by Mycone Dental Supply Co., T/A Keystone Industries.

What is the FDA product code for ClearMet?

The FDA product code for ClearMet is EBI.

Related Devices (Code: EBI)

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.