FDA 510(k)

ClearMet

K-Number: K152051 · 2016-03-22

ApplicantMycone Dental Supply Co., T/A Keystone Industries

Decision Date2016-03-22

Product CodeEBI

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

ClearMet is the device name listed in this FDA 510(k) record. The listed applicant is Mycone Dental Supply Co., T/A Keystone Industries. It received FDA 510(k) clearance on 2016-03-22 under 510(k) 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. The listed applicant is Mycone Dental Supply Co., T/A Keystone Industries. The 510(k) number is K152051.

When did ClearMet receive FDA 510(k) clearance?

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

Who is the listed applicant for ClearMet?

The FDA 510(k) record lists Mycone Dental Supply Co., T/A Keystone Industries as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ClearMet?

The FDA product code for ClearMet is EBI.

Related Devices (Code: EBI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261626UltraPrint Flexible Denture UVGuangzhou Heygears IMC., Inc.K262681NanoCeram Resin3BFAB TEKNOLOJI A.S.K262300Denture Base Resin V2Formlabs Ohio, Inc.K261474DENTCA Tru FlexibleDentca, Inc.K260569DB 4000 High Impact Denture BaseCarbon, Inc.K260376Denture BaseShandong Huge Dental Material Corporation

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.