Medical Device Manufacturer · US , Mchenry , IL

Parkell, Inc. - FDA 510(k) Cleared Devices

53 submissions · 53 cleared · Since 1976

Recent clearances: Parkell Pit and Fissure Sealant, Parkell Self-Adhesive Cement, Parkell Desensitizer Gel

53

Total

53

Cleared

0

Denied

FDA 510(k) Regulatory Record - Parkell, Inc. Dental ✕

53 devices

1-12 of 53

Cleared Aug 08, 2025

Parkell Pit and Fissure Sealant

Cleared Jan 20, 2022

Parkell Self-Adhesive Cement

Cleared Nov 22, 2019

Parkell Desensitizer Gel

Cleared Sep 05, 2019

Cleared Dec 14, 2018

Cleared Nov 21, 2017

Parkell Universal Adhesive

Cleared Sep 18, 2015

BRUSH&BOND PLUS

Cleared Feb 24, 2015

Cleared Jun 25, 2014

ABSOLUTE DENTIN 2

Cleared Apr 12, 2012

RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE

Cleared Jun 10, 2010

RETRIEVE IMPLANT CEMENT

Cleared May 13, 2008

DURAFINISH ALL-CURE, MODEL S296

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Data Source

Sourced from the FDA 510(k) public files . 175,218 total devices indexed.

Last updated: Apr 27, 2026