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FDA 510(k)

GLASS IONOMER CEMENT

K-Number: K914318 · 1992-03-20

ApplicantConfi-Dental Products Co.
Decision Date1992-03-20
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GLASS IONOMER CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Confi-Dental Products Co.. It received FDA 510(k) clearance on 1992-03-20 under 510(k) number K914318. 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 GLASS IONOMER CEMENT?

GLASS IONOMER CEMENT is a medical device that received FDA 510(k) clearance on 1992-03-20. The listed applicant is Confi-Dental Products Co.. The 510(k) number is K914318.

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

GLASS IONOMER CEMENT received FDA 510(k) clearance on 1992-03-20, under 510(k) number K914318.

Who is the listed applicant for GLASS IONOMER CEMENT?

The FDA 510(k) record lists Confi-Dental Products Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GLASS IONOMER CEMENT?

The FDA product code for GLASS IONOMER CEMENT is EMA.

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Other records listing Confi-Dental Products Co. 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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