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FDA 510(k)

MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED

K-Number: K973541 · 1997-11-25

ApplicantMedental Intl.
Decision Date1997-11-25
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED is the device name listed in this FDA 510(k) record. The listed applicant is Medental Intl.. It received FDA 510(k) clearance on 1997-11-25 under 510(k) number K973541. The device is classified under product code EBC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED?

MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED is a medical device that received FDA 510(k) clearance on 1997-11-25. The listed applicant is Medental Intl.. The 510(k) number is K973541.

When did MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED receive FDA 510(k) clearance?

MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED received FDA 510(k) clearance on 1997-11-25, under 510(k) number K973541.

Who is the listed applicant for MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED?

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 MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED?

The FDA product code for MEDENTAL CHEMICAL CURING SEALANT PIT & FISSURE TINTED is EBC.

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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 CEMENTK973919CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)

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Related Devices (Code: EBC)

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.

K260819Any-Com SealMediclus Co., Ltd.K243254Parkell Pit and Fissure SealantParkell, Inc.K232498UltraSeal XT plus - Bioprotection by Nobio, UltraSeal XT hydro - Bioprotection by NobioUltradent Product, Inc.K230455Enamel Coating ResinRizhao Huge Biomaterials Company, Ltd.K190998BA Pit & Fissure SealantApex Dental Materials, Inc.K190339Helioseal F PlusIvoclar Vivadent, AG

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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