DeviceClearance

Parkell Pit and Fissure Sealant— 510(k) K243254

Substantially Equivalent

Parkell, Inc.

FDA 510(k) clearance K243254 for Parkell Pit and Fissure Sealant, Substantially Equivalent on 2025-08-08. Applicant: Parkell, Inc..

Clearance details

Applicant
Parkell, Inc.
Product code
Code EBC
Advisory panel
Dental
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Abbreviated
Location
Edgewood, NJ, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.