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FDA 510(k)

FUJI IONOMER TYPE I & II

K-Number: K811521 · 1981-06-26

ApplicantG-C Intl. Corp.
Decision Date1981-06-26
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FUJI IONOMER TYPE I & II is the device name listed in this FDA 510(k) record. The listed applicant is G-C Intl. Corp.. It received FDA 510(k) clearance on 1981-06-26 under 510(k) number K811521. 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 FUJI IONOMER TYPE I & II?

FUJI IONOMER TYPE I & II is a medical device that received FDA 510(k) clearance on 1981-06-26. The listed applicant is G-C Intl. Corp.. The 510(k) number is K811521.

When did FUJI IONOMER TYPE I & II receive FDA 510(k) clearance?

FUJI IONOMER TYPE I & II received FDA 510(k) clearance on 1981-06-26, under 510(k) number K811521.

Who is the listed applicant for FUJI IONOMER TYPE I & II?

The FDA 510(k) record lists G-C Intl. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUJI IONOMER TYPE I & II?

The FDA product code for FUJI IONOMER TYPE I & II is EMA.

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Other records listing G-C Intl. 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.

K913175MIRACLE MIX CAPS GLASS IONOMER CEMENT INCAPSULESK913884FUJI II LCK901999FUJI LINING CEMENT LIGHT CUREK902531EXAPHASE, SINGLE PHASE IMPRESSION MATERIALK896883GC CERVICAL CEMENTK895976TOOTH SHADE RESIN

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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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