Cleared Traditional

K113839 - RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE

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

FDA 510(k) Submission Details - K113839

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.

MVL Device Classification - Class 0,

Product Code MVL Cord, Retraction
Device Class -

Regulatory Peers - MVL Cord, Retraction

All 32
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