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 a medical device manufactured by Parkell, Inc.. It received FDA 510(k) clearance on 2025-08-08 under approval 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. It is manufactured by Parkell, Inc.. The 510(k) number is K243254.
When was Parkell Pit and Fissure Sealant approved by the FDA?
Parkell Pit and Fissure Sealant received FDA 510(k) clearance on 2025-08-08, under approval number K243254.
What company makes Parkell Pit and Fissure Sealant?
Parkell Pit and Fissure Sealant is manufactured by Parkell, Inc..
What is the FDA product code for Parkell Pit and Fissure Sealant?
The FDA product code for Parkell Pit and Fissure Sealant is EBC.
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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.