Cleared Traditional

K092384 - LIQUICORD

K092384 · Centrix, Inc. · Dental device
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Nov 2009
Decision
91d
Days
-
Risk

K092384 is an FDA 510(k) clearance for the LIQUICORD. Classified as Cord, Retraction (product code MVL).

Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on November 4, 2009 after a review of 91 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 Centrix, Inc. devices

FDA 510(k) Submission Details - K092384

510(k) Number K092384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2009
Decision Date November 04, 2009
Days to Decision 91 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 127d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

MVL Device Classification - Class 0,

Product Code MVL Cord, Retraction
Device Class -