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510(k) K111348

RE / STASIS (TM) GINGIVAL RETRACTION PASTE by Centrix, Inc. — Product Code MVL

K111348 is an FDA 510(k) premarket notification submitted by Centrix, Inc. for the device "RE / STASIS (TM) GINGIVAL RETRACTION PASTE". The FDA issued a decision of Substantially Equivalent on July 22, 2011. The device falls under product code MVL (Cord, Retraction), a Class U device. Centrix, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 2011
Date Received
May 13, 2011
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cord, Retraction
Device Class
Class U
Regulation Number
Review Panel
DE
Submission Type

Other clearances by Centrix, Inc.

  • K250714 — FluoroDose Varnish (November 21, 2025)
  • K222459 — Centrix FluoroSilver Silver Diamine Fluoride 38% (October 27, 2023)
  • K152826 — NoCord (May 27, 2016)
  • K140144 — BENDA WEDGE (July 8, 2014)
  • K120176 — SENZZZZZ AWAY (July 25, 2012)
  • K092384 — LIQUICORD (November 4, 2009)
  • K091380 — CORDCAP (July 30, 2009)
  • K021131 — CHLORAPREP (September 26, 2002)
  • K021146 — D/SENSE 1-STEP (July 2, 2002)
  • K010133 — VERSALUX (April 5, 2001)

Other clearances for product code MVL

  • K254239 — CyClean Cord (March 27, 2026)
  • K253797 — One-Stop (February 27, 2026)
  • K243910 — Retraxil (September 24, 2025)
  • K211420 — Stasis Gel (March 14, 2022)
  • K211419 — Gingi-Aid Gel (January 10, 2022)
  • K213149 — VOCO Retraction Paste (December 9, 2021)
  • K200764 — STATSTIX (October 15, 2020)
  • K193389 — Vista Clear (March 4, 2020)
  • K190220 — Vista FS, Vista FS Liquid (June 10, 2019)
  • K171577 — Smartcord, Smartcord X (May 3, 2018)

FDA data resources