Cleared Traditional

K131799 - QUICKNIT (FDA 510(k) Clearance)

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

Submission Details

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.

Device Classification

Product Code MVL Cord, Retraction
Device Class -

Regulatory Peers - MVL Cord, Retraction

All 35
Devices cleared under the same product code (MVL) and FDA review panel - the closest regulatory comparables to K131799.
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VOCO Retraction Paste
K213149 · Voco GmbH · Dec 2021