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FDA 510(k)

COMMAND ULTRASEAL PIT & FISSURE SEALANT

K-Number: K843024 · 1984-09-27

ApplicantKerr Corporation (Danbury)
Decision Date1984-09-27
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

COMMAND ULTRASEAL PIT & FISSURE SEALANT is the device name listed in this FDA 510(k) record. The listed applicant is Kerr Corporation (Danbury). It received FDA 510(k) clearance on 1984-09-27 under 510(k) number K843024. 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 COMMAND ULTRASEAL PIT & FISSURE SEALANT?

COMMAND ULTRASEAL PIT & FISSURE SEALANT is a medical device that received FDA 510(k) clearance on 1984-09-27. The listed applicant is Kerr Corporation (Danbury). The 510(k) number is K843024.

When did COMMAND ULTRASEAL PIT & FISSURE SEALANT receive FDA 510(k) clearance?

COMMAND ULTRASEAL PIT & FISSURE SEALANT received FDA 510(k) clearance on 1984-09-27, under 510(k) number K843024.

Who is the listed applicant for COMMAND ULTRASEAL PIT & FISSURE SEALANT?

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

What is the FDA product code for COMMAND ULTRASEAL PIT & FISSURE SEALANT?

The FDA product code for COMMAND ULTRASEAL PIT & FISSURE SEALANT is EBC.

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Other records listing Kerr Corporation (Danbury) 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.

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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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