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FDA 510(k)

AEGIS PIT & FISSURE SEALANT WITH ACP

K-Number: K033751 · 2004-02-05

ApplicantHarry J. Bosworth Co.
Decision Date2004-02-05
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

AEGIS PIT & FISSURE SEALANT WITH ACP is the device name listed in this FDA 510(k) record. The listed applicant is Harry J. Bosworth Co.. It received FDA 510(k) clearance on 2004-02-05 under 510(k) number K033751. 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 AEGIS PIT & FISSURE SEALANT WITH ACP?

AEGIS PIT & FISSURE SEALANT WITH ACP is a medical device that received FDA 510(k) clearance on 2004-02-05. The listed applicant is Harry J. Bosworth Co.. The 510(k) number is K033751.

When did AEGIS PIT & FISSURE SEALANT WITH ACP receive FDA 510(k) clearance?

AEGIS PIT & FISSURE SEALANT WITH ACP received FDA 510(k) clearance on 2004-02-05, under 510(k) number K033751.

Who is the listed applicant for AEGIS PIT & FISSURE SEALANT WITH ACP?

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

What is the FDA product code for AEGIS PIT & FISSURE SEALANT WITH ACP?

The FDA product code for AEGIS PIT & FISSURE SEALANT WITH ACP is EBC.

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Other records listing Harry J. Bosworth Co. 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.

K103585BOSWORTH AEGIS LINER & RESTORATIVE MATERIAL W/ACPK100731BOSWORTH AIR POLISHERK061611BOSWORTH DENTIN RESINK051224BOSWORTH SEALK043170BOSWORTH BONDK040548AEGIS ORTHO LIGHT-CURED ORTHODONTIC ADHESIVE

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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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