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FDA 510(k)

MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE

K-Number: K924824 · 1993-03-16

ApplicantUnicep
Decision Date1993-03-16
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE is the device name listed in this FDA 510(k) record. The listed applicant is Unicep. It received FDA 510(k) clearance on 1993-03-16 under 510(k) number K924824. 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 MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE?

MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE is a medical device that received FDA 510(k) clearance on 1993-03-16. The listed applicant is Unicep. The 510(k) number is K924824.

When did MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE receive FDA 510(k) clearance?

MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE received FDA 510(k) clearance on 1993-03-16, under 510(k) number K924824.

Who is the listed applicant for MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE?

The FDA 510(k) record lists Unicep as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE?

The FDA product code for MICRODOSE PIT AND FISSURE SEALANT-CLEAR OR WHITE is EBC.

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Other records listing Unicep 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.

K925163MICODOSE CHLORHEXIPREPK924821MICRODOSE PORCELAIN ETCHANTK924823MICRODOSE SILANEK925162MICRODOSE DENTIN CONDITIONERK924825MICRODOSE RC-EZK924822MICRODOSE ENAMEL ETCHANT

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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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