Cleared Traditional

K091380 - CORDCAP (FDA 510(k) Clearance)

K091380 · Centrix, Inc. · Dental device
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Optimized for regulatory review, auditing and printing
Jul 2009
Decision
80d
Days
-
Risk

K091380 is an FDA 510(k) clearance for the CORDCAP. Classified as Cord, Retraction (product code MVL).

Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on July 30, 2009 after a review of 80 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Centrix, Inc. devices

Submission Details

510(k) Number K091380 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2009
Decision Date July 30, 2009
Days to Decision 80 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
47d faster than avg
Panel avg: 127d · This submission: 80d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVL Cord, Retraction
Device Class -