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FDA 510(k)

POLYCARBOXYLATE CEMENT

K-Number: K980990 · 1998-07-31

ApplicantMedental Intl.
Decision Date1998-07-31
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

POLYCARBOXYLATE CEMENT is the device name listed in this FDA 510(k) record. The listed applicant is Medental Intl.. It received FDA 510(k) clearance on 1998-07-31 under 510(k) number K980990. 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 POLYCARBOXYLATE CEMENT?

POLYCARBOXYLATE CEMENT is a medical device that received FDA 510(k) clearance on 1998-07-31. The listed applicant is Medental Intl.. The 510(k) number is K980990.

When did POLYCARBOXYLATE CEMENT receive FDA 510(k) clearance?

POLYCARBOXYLATE CEMENT received FDA 510(k) clearance on 1998-07-31, under 510(k) number K980990.

Who is the listed applicant for POLYCARBOXYLATE CEMENT?

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

What is the FDA product code for POLYCARBOXYLATE CEMENT?

The FDA product code for POLYCARBOXYLATE CEMENT is EMA.

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Other records listing Medental Intl. 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.

K990314MULTI-CURE COMPOSITE CEMENTK983018ZINC PHOSPHATE CEMENTK982779MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1K982191CHEMICAL CURE COMPOSITE WITH ENAMEL BONDK973919CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)K973541MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED

View all 7 devices →

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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