FDA 510(k)

Keymill

K-Nummer: K172764 · 2018-04-27

AntragstellerMycone Dental Supply Company, Inc. (Aka Keystone Industries)

Entscheidungsdatum2018-04-27

ProduktcodeEBI

BeratungsausschussDE

EntscheidungSubstantially Equivalent

Produktübersicht

Keymill is the device name listed in this FDA 510(k) record. The listed applicant is Mycone Dental Supply Company, Inc. (Aka Keystone Industries). It received FDA 510(k) clearance on 2018-04-27 under 510(k) number K172764. 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 Keymill?

Keymill is a medical device that received FDA 510(k) clearance on 2018-04-27. The listed applicant is Mycone Dental Supply Company, Inc. (Aka Keystone Industries). The 510(k) number is K172764.

When did Keymill receive FDA 510(k) clearance?

Keymill received FDA 510(k) clearance on 2018-04-27, under 510(k) number K172764.

Who is the listed applicant for Keymill?

The FDA 510(k) record lists Mycone Dental Supply Company, Inc. (Aka Keystone Industries) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Keymill?

The FDA product code for Keymill 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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