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FDA 510(k)

KULZER GLASS IONOMER LINER

K-Number: K863141 · 1986-08-26

ApplicantShofu Dental Corp.
Decision Date1986-08-26
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

KULZER GLASS IONOMER LINER 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 1986-08-26 under 510(k) number K863141. 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 KULZER GLASS IONOMER LINER?

KULZER GLASS IONOMER LINER is a medical device that received FDA 510(k) clearance on 1986-08-26. The listed applicant is Shofu Dental Corp.. The 510(k) number is K863141.

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

KULZER GLASS IONOMER LINER received FDA 510(k) clearance on 1986-08-26, under 510(k) number K863141.

Who is the listed applicant for KULZER GLASS IONOMER LINER?

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 KULZER GLASS IONOMER LINER?

The FDA product code for KULZER GLASS IONOMER LINER 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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