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510(k) K200764

STATSTIX by Centrix Incorporated — Product Code MVL

K200764 is an FDA 510(k) premarket notification submitted by Centrix Incorporated for the device "STATSTIX". The FDA issued a decision of Substantially Equivalent on October 15, 2020. The device falls under product code MVL (Cord, Retraction), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2020
Date Received
March 24, 2020
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 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)
  • K193389 — Vista Clear (March 4, 2020)
  • K190220 — Vista FS, Vista FS Liquid (June 10, 2019)
  • K171577 — Smartcord, Smartcord X (May 3, 2018)
  • K162662 — GingiDent Gingival Retraction Paste (October 20, 2017)

FDA data resources