Cleared Traditional

K131799 - QUICKNIT

K131799 · Microcopy, Div. of Neo-Flo, Inc. · Dental device
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Jan 2014
Decision
211d
Days
-
Risk

K131799 is an FDA 510(k) clearance for the QUICKNIT. Classified as Cord, Retraction (product code MVL).

Submitted by Microcopy, Div. of Neo-Flo, Inc. (Kennesaw, US). The FDA issued a Cleared decision on January 16, 2014 after a review of 211 days - an extended review cycle.

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 Microcopy, Div. of Neo-Flo, Inc. devices

FDA 510(k) Submission Details - K131799

510(k) Number K131799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2013
Decision Date January 16, 2014
Days to Decision 211 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 127d · This submission: 211d
Pathway characteristics
Predicate-based equivalence.

MVL Device Classification - Class 0,

Product Code MVL Cord, Retraction
Device Class -

Regulatory Peers - MVL Cord, Retraction

All 28
Devices cleared under the same product code (MVL) and FDA review panel - the closest regulatory comparables to K131799.
GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord
K162164 · Kerr Corporation · Jan 2017
Astringedent Clear
K152064 · Ultradent Products, Inc. · Sep 2015
RETRACTION PASTE
K130580 · Dmg USA, Inc. · Feb 2014
KNIT-PAK+
K132526 · Premier Dental Products Co. · Nov 2013
VISCOSTAT CLEAR
K123215 · Ultradent Products, Inc. · Feb 2013
RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE
K113839 · Parkell, Inc. · Apr 2012