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FDA 510(k)

VARIGLASS VLC GLASS IONOMER

K-Number: K931229 · 1993-07-08

ApplicantDentsply Intl.
Decision Date1993-07-08
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

VARIGLASS VLC GLASS IONOMER is the device name listed in this FDA 510(k) record. The listed applicant is Dentsply Intl.. It received FDA 510(k) clearance on 1993-07-08 under 510(k) number K931229. 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 VARIGLASS VLC GLASS IONOMER?

VARIGLASS VLC GLASS IONOMER is a medical device that received FDA 510(k) clearance on 1993-07-08. The listed applicant is Dentsply Intl.. The 510(k) number is K931229.

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

VARIGLASS VLC GLASS IONOMER received FDA 510(k) clearance on 1993-07-08, under 510(k) number K931229.

Who is the listed applicant for VARIGLASS VLC GLASS IONOMER?

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

What is the FDA product code for VARIGLASS VLC GLASS IONOMER?

The FDA product code for VARIGLASS VLC GLASS IONOMER 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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