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FDA 510(k)

GLASIONOMER FX-II

K-Number: K031467 · 2003-07-17

ApplicantShofu Dental Corp.
Decision Date2003-07-17
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GLASIONOMER FX-II 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 2003-07-17 under 510(k) number K031467. 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 GLASIONOMER FX-II?

GLASIONOMER FX-II is a medical device that received FDA 510(k) clearance on 2003-07-17. The listed applicant is Shofu Dental Corp.. The 510(k) number is K031467.

When did GLASIONOMER FX-II receive FDA 510(k) clearance?

GLASIONOMER FX-II received FDA 510(k) clearance on 2003-07-17, under 510(k) number K031467.

Who is the listed applicant for GLASIONOMER FX-II?

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 GLASIONOMER FX-II?

The FDA product code for GLASIONOMER FX-II 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.

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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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