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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sealant, Pit And Fissure, And Conditioner
510(k) Number K243254
Device Name Parkell Pit and Fissure Sealant
Applicant
Parkell, Inc.
300 Executive Dr.
Edgewood,  NJ  11717
Applicant Contact David Mott
Correspondent
Fish & Richardson, P.C.
1000 Maine Ave., SW, Suite 1000
Washington,  DC  20024
Correspondent Contact Keith Barritt
Regulation Number872.3765
Classification Product Code
EBC  
Date Received10/15/2024
Decision Date 08/08/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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