Cleared Traditional

LIQUICORD (K092384) - FDA 510(k) Clearance

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

Submission Details

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
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 127d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVL Cord, Retraction
Device Class -

Regulatory Peers - MVL Cord, Retraction

All 35
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