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FDA 510(k)

MULTI-CURE COMPOSITE CEMENT

K-Number: K990314 · 1999-04-02

ApplicantMedental Intl.
Decision Date1999-04-02
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MULTI-CURE COMPOSITE 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 1999-04-02 under 510(k) number K990314. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MULTI-CURE COMPOSITE CEMENT?

MULTI-CURE COMPOSITE CEMENT is a medical device that received FDA 510(k) clearance on 1999-04-02. The listed applicant is Medental Intl.. The 510(k) number is K990314.

When did MULTI-CURE COMPOSITE CEMENT receive FDA 510(k) clearance?

MULTI-CURE COMPOSITE CEMENT received FDA 510(k) clearance on 1999-04-02, under 510(k) number K990314.

Who is the listed applicant for MULTI-CURE COMPOSITE 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 MULTI-CURE COMPOSITE CEMENT?

The FDA product code for MULTI-CURE COMPOSITE CEMENT is EBF.

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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.

K983018ZINC PHOSPHATE CEMENTK982779MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1K982191CHEMICAL CURE COMPOSITE WITH ENAMEL BONDK980990POLYCARBOXYLATE CEMENTK973919CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)K973541MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED

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Related Devices (Code: EBF)

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.

K262982Core·it DualSpident Co., Ltd.K262202Cerasmart ForteGC America, Inc.K261695Flowable Restorative Material (KP-Flow LF, KP-Flow MF, KP-Flow HF)Guilin Kevin Peter Technology Co., Ltd.K261485Tetric plus Fill;Tetric plus FlowIvoclar Vivadent, Inc.K262228Transcend Bulk Fill Flowable CompositeUltradent Products, Inc.K261246SRGC-06GC America, 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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