Cleared Traditional

RETRACTION PASTE (K130580) - FDA 510(k) Clearance

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

Submission Details

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
Regulatory Context
Review time vs. panel average
230d slower than avg
Panel avg: 127d · This submission: 357d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVL Cord, Retraction
Device Class -

Regulatory Peers - MVL Cord, Retraction

All 14
Devices cleared under the same product code (MVL) and FDA review panel - the closest regulatory comparables to K130580.
Vista FS, Vista FS Liquid
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Astringedent Clear
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VISCOSTAT CLEAR
K123215 · Ultradent Products, Inc. · Feb 2013
ULTRAPAK NEHA
K010070 · Ultradent Products, Inc. · Mar 2001
ULTRAPAK E
K981596 · Ultradent Products, Inc. · Jul 1998