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

Submission Details

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.

Device Classification

Product Code MVL Cord, Retraction
Device Class -

Regulatory Peers - MVL Cord, Retraction

All 13
Devices cleared under the same product code (MVL) and FDA review panel - the closest regulatory comparables to K123215.
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ULTRAPAK NEHA
K010070 · Ultradent Products, Inc. · Mar 2001
ULTRAPAK E
K981596 · Ultradent Products, Inc. · Jul 1998