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FDA 510(k)

LIGHT-CURED ZIONOMER CEMENT

K-Number: K881918 · 1988-07-15

ApplicantDen-Mat Corp.
Decision Date1988-07-15
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LIGHT-CURED ZIONOMER CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Den-Mat Corp.. It received FDA 510(k) clearance on 1988-07-15 under 510(k) number K881918. 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 LIGHT-CURED ZIONOMER CEMENT?

LIGHT-CURED ZIONOMER CEMENT is a medical device that received FDA 510(k) clearance on 1988-07-15. The listed applicant is Den-Mat Corp.. The 510(k) number is K881918.

When did LIGHT-CURED ZIONOMER CEMENT receive FDA 510(k) clearance?

LIGHT-CURED ZIONOMER CEMENT received FDA 510(k) clearance on 1988-07-15, under 510(k) number K881918.

Who is the listed applicant for LIGHT-CURED ZIONOMER CEMENT?

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

What is the FDA product code for LIGHT-CURED ZIONOMER CEMENT?

The FDA product code for LIGHT-CURED ZIONOMER CEMENT is EMA.

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Other records listing Den-Mat 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.

K9831061ST IMPRESSIONK895731DEN-MAT CERINATE PORCELAINK895269DEN-MAT LAMI-QUICKK875351DEN-MAT PORETCH (PORCELAIN ETCHANT)K872510DEN-MAT TENUREK870130DEN-MAT SECURE ANTI-ROTATIONAL POST-CORE SYSTEM

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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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