Cleared Traditional

K130580 - RETRACTION PASTE

K130580 · Dmg USA, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2014
Decision
357d
Days
-
Risk

K130580 is an FDA 510(k) clearance for the RETRACTION PASTE. Classified as Cord, Retraction (product code MVL).

Submitted by Dmg USA, Inc. (Ayer, US). The FDA issued a Cleared decision on February 25, 2014 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Dmg USA, Inc. devices

FDA 510(k) Submission Details - K130580

510(k) Number K130580 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2013
Decision Date February 25, 2014
Days to Decision 357 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
230d slower than avg
Panel avg: 127d · This submission: 357d
Pathway characteristics
Predicate-based equivalence.

MVL Device Classification - Class 0,

Product Code MVL Cord, Retraction
Device Class -

Regulatory Peers - MVL Cord, Retraction

All 27
Devices cleared under the same product code (MVL) and FDA review panel - the closest regulatory comparables to K130580.
GingiKnit+, GingiBraid+, GingiBraid+ Shortcut, and UniBraid+ impregnated Aluminum Potassium Sulfate Retraction Cord
K162536 · Kerr Corporation · Feb 2017
GingiKnit+, GingiBraid+, and Shortcut with GingiBraid+ Non-Impregnated Retraction Cord
K162164 · Kerr Corporation · Jan 2017
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
RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE
K113839 · Parkell, Inc. · Apr 2012