Search FDA 510(k) Clearance Records

Use this 510(k) search tool to find FDA medical device clearance records by K-number, device name, manufacturer, product code, or regulatory consultant. Explore individual submissions, review timelines, predicate device information, and links to official FDA records. Search the database for free, with no registration required.

176,583 clearances · 1976 to present · Updated monthly from FDA records · Free access · No registration required

53 results for "Parkell, Inc."

1–24 of 53

Search insights Median review: 72d Cleared: 100% Top manufacturer: Parkell, Inc. Lead specialty: Dental

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

Cleared Mar 19, 2008

Cleared Dec 04, 2006

Cleared Nov 28, 2006

Cleared Jun 15, 2006

Cleared Jan 26, 2006

Cleared Apr 09, 2004

PARKELL RESIN GLAZE

Cleared Sep 09, 2003

Cleared Jul 11, 2003

TEMPORARY RESIN CEMENT

Cleared Sep 06, 2002

Cleared Mar 20, 2002

TOUCH&BOND-PLUS

Cleared Sep 06, 2001

LC TEMPORARY FILLING

Cleared May 07, 2001

D/C CORE MATERIAL