Cleared Traditional

K113839 - RETRACT GINGIVAL RETRACTION/HEMOSTATIC ...

K113839 · Parkell, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
106d
Days
-
Risk

K113839 is an FDA 510(k) clearance for the RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE. Classified as Cord, Retraction (product code MVL).

Submitted by Parkell, Inc. (Edgewood, US). The FDA issued a Cleared decision on April 12, 2012 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Parkell, Inc. devices

Submission Details

510(k) Number K113839 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 28, 2011
Decision Date April 12, 2012
Days to Decision 106 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 127d · This submission: 106d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVL Cord, Retraction
Device Class -

Regulatory Peers - MVL Cord, Retraction

All 19
Devices cleared under the same product code (MVL) and FDA review panel - the closest regulatory comparables to K113839.
Astringedent Clear
K152064 · Ultradent Products, Inc. · Sep 2015
KNIT-PAK+
K132526 · Premier Dental Products Co. · Nov 2013
VISCOSTAT CLEAR
K123215 · Ultradent Products, Inc. · Feb 2013
RE / STASIS (TM) GINGIVAL RETRACTION PASTE
K111348 · Centrix, Inc. · Jul 2011
LIQUICORD
K092384 · Centrix, Inc. · Nov 2009
CORDCAP
K091380 · Centrix, Inc. · Jul 2009