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FDA 510(k)

FOREMOST LITE CURE PIT & FISSURE SEALANT

K-Number: K845034 · 1985-03-18

ApplicantForemost Dental Mfg., Inc.
Decision Date1985-03-18
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FOREMOST LITE CURE PIT & FISSURE SEALANT is the device name listed in this FDA 510(k) record. The listed applicant is Foremost Dental Mfg., Inc.. It received FDA 510(k) clearance on 1985-03-18 under 510(k) number K845034. 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 FOREMOST LITE CURE PIT & FISSURE SEALANT?

FOREMOST LITE CURE PIT & FISSURE SEALANT is a medical device that received FDA 510(k) clearance on 1985-03-18. The listed applicant is Foremost Dental Mfg., Inc.. The 510(k) number is K845034.

When did FOREMOST LITE CURE PIT & FISSURE SEALANT receive FDA 510(k) clearance?

FOREMOST LITE CURE PIT & FISSURE SEALANT received FDA 510(k) clearance on 1985-03-18, under 510(k) number K845034.

Who is the listed applicant for FOREMOST LITE CURE PIT & FISSURE SEALANT?

The FDA 510(k) record lists Foremost Dental Mfg., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FOREMOST LITE CURE PIT & FISSURE SEALANT?

The FDA product code for FOREMOST LITE CURE PIT & FISSURE SEALANT is EBC.

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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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