FDA 510(k)

ClearMet

K-Nummer: K152051 · 2016-03-22

AntragstellerMycone Dental Supply Co., T/A Keystone Industries

Entscheidungsdatum2016-03-22

ProduktcodeEBI

BeratungsausschussDE

EntscheidungSubstantially Equivalent

Produktübersicht

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.

Häufig gestellte Fragen

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.

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Verwandte Geräte (Code: EBI)

K261802Glidewell™ Denture Base ResinPrismatik Dentalcraft, Inc.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.

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