RE / STASIS (TM) GINGIVAL RETRACTION PASTE— 510(k) K111348

Name: FDA 510(k) clearance K111348
Creator: U.S. Food and Drug Administration
Published: 2011-07-22

Substantially Equivalent

Centrix, Inc.

FDA 510(k) clearance K111348 for RE / STASIS (TM) GINGIVAL RETRACTION PASTE, Substantially Equivalent on 2011-07-22. Applicant: Centrix, Inc.. Device class: Unclassified.

Clearance details

Applicant: Centrix, Inc.
Product code: Code MVL
Device class: Unclassified
Advisory panel: Unknown
Date received: 2011-05-13
Decision date: 2011-07-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shelton, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MVL

view all

K254239 — CyClean Cord2026-03-27
K253797 — One-Stop2026-02-27
K243910 — Retraxil2025-09-24
K211420 — Stasis Gel2022-03-14
K211419 — Gingi-Aid Gel2022-01-10

More clearances from Centrix, Inc.

view all

K250714 — FluoroDose Varnish2025-11-21
K222459 — Centrix FluoroSilver Silver Diamine Fluoride 38%2023-10-27
K152826 — NoCord2016-05-27
K140144 — BENDA WEDGE2014-07-08
K120176 — SENZZZZZ AWAY2012-07-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.