Cleared Traditional

K123215 - VISCOSTAT CLEAR

K123215 · Ultradent Products, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2013
Decision
113d
Days
-
Risk

K123215 is an FDA 510(k) clearance for the VISCOSTAT CLEAR. Classified as Cord, Retraction (product code MVL).

Submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on February 5, 2013 after a review of 113 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 Ultradent Products, Inc. devices

FDA 510(k) Submission Details - K123215

510(k) Number K123215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2012
Decision Date February 05, 2013
Days to Decision 113 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
14d faster than avg
Panel avg: 127d · This submission: 113d
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 K123215.
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
RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE
K113839 · Parkell, Inc. · Apr 2012
SULCUS BLUE
K111978 · Produits Dentaires Pierre Rolland · Oct 2011
RE / STASIS (TM) GINGIVAL RETRACTION PASTE
K111348 · Centrix, Inc. · Jul 2011