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FDA 510(k)

GLAS IONOMER CEMENT

K-Number: K850913 · 1985-04-10

ApplicantShofu Dental Corp.
Decision Date1985-04-10
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GLAS IONOMER CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Shofu Dental Corp.. It received FDA 510(k) clearance on 1985-04-10 under 510(k) number K850913. 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 GLAS IONOMER CEMENT?

GLAS IONOMER CEMENT is a medical device that received FDA 510(k) clearance on 1985-04-10. The listed applicant is Shofu Dental Corp.. The 510(k) number is K850913.

When did GLAS IONOMER CEMENT receive FDA 510(k) clearance?

GLAS IONOMER CEMENT received FDA 510(k) clearance on 1985-04-10, under 510(k) number K850913.

Who is the listed applicant for GLAS IONOMER CEMENT?

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

What is the FDA product code for GLAS IONOMER CEMENT?

The FDA product code for GLAS IONOMER CEMENT is EMA.

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Other records listing Shofu Dental Corp. as applicant

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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

View on FDA Database →

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

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