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FDA 510(k)

HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE

K-Number: K945451 · 1995-02-27

ApplicantShofu Dental Corp.
Decision Date1995-02-27
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE 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 1995-02-27 under 510(k) number K945451. 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 HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE?

HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE is a medical device that received FDA 510(k) clearance on 1995-02-27. The listed applicant is Shofu Dental Corp.. The 510(k) number is K945451.

When did HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE receive FDA 510(k) clearance?

HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE received FDA 510(k) clearance on 1995-02-27, under 510(k) number K945451.

Who is the listed applicant for HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE?

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 HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE?

The FDA product code for HI DENSE, GLASS IONOMER SILVER REINFORCED RESTORATIVE is EMA.

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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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