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Parkell, Inc.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
61
Inspections
4
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K243254Parkell Pit and Fissure SealantAugust 8, 2025
K210259Parkell Self-Adhesive CementJanuary 20, 2022
K191103Parkell Desensitizer GelNovember 22, 2019
K190930SmarTemp X1September 5, 2019
K182296HyperFil-LVDecember 14, 2018
K172176Parkell Universal AdhesiveNovember 21, 2017
K151518BRUSH&BOND PLUSSeptember 18, 2015
K142848EAZY PRIMERFebruary 24, 2015
K132115ABSOLUTE DENTIN 2June 25, 2014
K113839RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTEApril 12, 2012
K101044RETRIEVE IMPLANT CEMENTJune 10, 2010
K080549DURAFINISH ALL-CURE, MODEL S296May 13, 2008
K073698SECUREMarch 19, 2008
K062518CELERITYDecember 4, 2006
K063003AURORANovember 28, 2006
K060946CZ-S2000June 15, 2006
K053516MUCOHARDJanuary 26, 2006
K040599PARKELL RESIN GLAZEApril 9, 2004
K032179COMP. ESeptember 9, 2003
K031212TEMPORARY RESIN CEMENTJuly 11, 2003