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FDA 510(k)

TYPE I GLASS IONOMER CEMENT

K-Number: K942808 · 1994-11-03

ApplicantMion International Corp.
Decision Date1994-11-03
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TYPE I GLASS IONOMER CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Mion International Corp.. It received FDA 510(k) clearance on 1994-11-03 under 510(k) number K942808. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TYPE I GLASS IONOMER CEMENT?

TYPE I GLASS IONOMER CEMENT is a medical device that received FDA 510(k) clearance on 1994-11-03. The listed applicant is Mion International Corp.. The 510(k) number is K942808.

When did TYPE I GLASS IONOMER CEMENT receive FDA 510(k) clearance?

TYPE I GLASS IONOMER CEMENT received FDA 510(k) clearance on 1994-11-03, under 510(k) number K942808.

Who is the listed applicant for TYPE I GLASS IONOMER CEMENT?

The FDA 510(k) record lists Mion International Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TYPE I GLASS IONOMER CEMENT?

The FDA product code for TYPE I GLASS IONOMER CEMENT is EMA.

Related Clinical Trials

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Other records listing Mion International Corp. as applicant

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.

K926376MION 525K915666AMALCODEN

Related Devices (Code: EMA)

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.

K262983EsTemp ImplantSpident Co., Ltd.K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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