Cleared Traditional

K111348 - RE / STASIS (TM) GINGIVAL RETRACTION PASTE (FDA 510(k) Clearance)

K111348 · Centrix, Inc. · Dental device
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Jul 2011
Decision
70d
Days
-
Risk

K111348 is an FDA 510(k) clearance for the RE / STASIS (TM) GINGIVAL RETRACTION PASTE. Classified as Cord, Retraction (product code MVL).

Submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on July 22, 2011 after a review of 70 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 K111348 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 13, 2011
Decision Date July 22, 2011
Days to Decision 70 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
57d faster than avg
Panel avg: 127d · This submission: 70d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code MVL Cord, Retraction
Device Class -