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FDA 510(k)

CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)

K-Number: K973919 · 1997-12-16

ApplicantMedental Intl.
Decision Date1997-12-16
Product CodeLBH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL) is the device name listed in this FDA 510(k) record. The listed applicant is Medental Intl.. It received FDA 510(k) clearance on 1997-12-16 under 510(k) number K973919. The device is classified under product code LBH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)?

CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL) is a medical device that received FDA 510(k) clearance on 1997-12-16. The listed applicant is Medental Intl.. The 510(k) number is K973919.

When did CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL) receive FDA 510(k) clearance?

CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL) received FDA 510(k) clearance on 1997-12-16, under 510(k) number K973919.

Who is the listed applicant for CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)?

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 CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)?

The FDA product code for CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL) is LBH.

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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 BONDK980990POLYCARBOXYLATE CEMENTK973541MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED

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Related Devices (Code: LBH)

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.

K262243Profisil FreeKettenbach GmbH & Co. KGK253052Fluoride Varnish (Type A,Type C)Nagy Oral Technology Qinhuangdao Co., Ltd.K252073VOCO Profluorid Varnish + BioMinVoco GmbHK261404UltraEZUltradent Products, Inc.K260830APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)Sangi Co., Ltd.K250714FluoroDose VarnishCentrix, 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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