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FDA 510(k)

Parkell Pit and Fissure Sealant

K-Number: K243254 · 2025-08-08

ApplicantParkell, Inc.
Decision Date2025-08-08
Product CodeEBC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Parkell Pit and Fissure Sealant is the device name listed in this FDA 510(k) record. The listed applicant is Parkell, Inc.. It received FDA 510(k) clearance on 2025-08-08 under 510(k) number K243254. 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 Parkell Pit and Fissure Sealant?

Parkell Pit and Fissure Sealant is a medical device that received FDA 510(k) clearance on 2025-08-08. The listed applicant is Parkell, Inc.. The 510(k) number is K243254.

When did Parkell Pit and Fissure Sealant receive FDA 510(k) clearance?

Parkell Pit and Fissure Sealant received FDA 510(k) clearance on 2025-08-08, under 510(k) number K243254.

Who is the listed applicant for Parkell Pit and Fissure Sealant?

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

What is the FDA product code for Parkell Pit and Fissure Sealant?

The FDA product code for Parkell Pit and Fissure Sealant is EBC.

Related Clinical Trials

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.

NCT07725133Clinical Evaluation of the Retention of Fissure Sealants Applied Following Guided Biofilm Therapy and Conventional PolishingNOT_YET_RECRUITING

Other records listing Parkell, 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.

K210259Parkell Self-Adhesive CementK191103Parkell Desensitizer GelK190930SmarTemp X1K182296HyperFil-LVK172176Parkell Universal Adhesive

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.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, AGK172169Pulpdent (Activa) Pit and Fissure Sealant with MCPPulpdent Corporation

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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