Cleared Traditional

K113839 - RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE (FDA 510(k) Clearance)

K113839 · Parkell, Inc. · Dental device
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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
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 -