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FDA 510(k)

CHEMICAL CURE COMPOSITE WITH ENAMEL BOND

K-Number: K982191 · 1998-09-14

ApplicantMedental Intl.
Decision Date1998-09-14
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CHEMICAL CURE COMPOSITE WITH ENAMEL BOND is the device name listed in this FDA 510(k) record. The listed applicant is Medental Intl.. It received FDA 510(k) clearance on 1998-09-14 under 510(k) number K982191. 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 CHEMICAL CURE COMPOSITE WITH ENAMEL BOND?

CHEMICAL CURE COMPOSITE WITH ENAMEL BOND is a medical device that received FDA 510(k) clearance on 1998-09-14. The listed applicant is Medental Intl.. The 510(k) number is K982191.

When did CHEMICAL CURE COMPOSITE WITH ENAMEL BOND receive FDA 510(k) clearance?

CHEMICAL CURE COMPOSITE WITH ENAMEL BOND received FDA 510(k) clearance on 1998-09-14, under 510(k) number K982191.

Who is the listed applicant for CHEMICAL CURE COMPOSITE WITH ENAMEL BOND?

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 CHEMICAL CURE COMPOSITE WITH ENAMEL BOND?

The FDA product code for CHEMICAL CURE COMPOSITE WITH ENAMEL BOND 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.

K990314MULTI-CURE COMPOSITE CEMENTK983018ZINC PHOSPHATE CEMENTK982779MEDENTAL GLASS IONOMER CEMENT TYPE I AND MIRAGE GLASS IONOMER CEMENT TYPE 1K980990POLYCARBOXYLATE 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.

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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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