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FDA 510(k)

BISCO PIT AND FISSURE SEALANT

K-Number: K874556 · 1988-01-28

ApplicantBisco, Inc.
Decision Date1988-01-28
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BISCO PIT AND FISSURE SEALANT is the device name listed in this FDA 510(k) record. The listed applicant is Bisco, Inc.. It received FDA 510(k) clearance on 1988-01-28 under 510(k) number K874556. 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 BISCO PIT AND FISSURE SEALANT?

BISCO PIT AND FISSURE SEALANT is a medical device that received FDA 510(k) clearance on 1988-01-28. The listed applicant is Bisco, Inc.. The 510(k) number is K874556.

When did BISCO PIT AND FISSURE SEALANT receive FDA 510(k) clearance?

BISCO PIT AND FISSURE SEALANT received FDA 510(k) clearance on 1988-01-28, under 510(k) number K874556.

Who is the listed applicant for BISCO PIT AND FISSURE SEALANT?

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

What is the FDA product code for BISCO PIT AND FISSURE SEALANT?

The FDA product code for BISCO PIT AND FISSURE SEALANT is EBC.

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Other records listing Bisco, Inc. 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.

K250156Choice 2 DCK242816QuantiumK192007TheraBase, TheraBase CaK182917FluoroCalK180344TheraCal DCK171147REVEAL Bulk

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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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