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510(k) K193389

Vista Clear by Inter-Med/Vista Dental Products — Product Code MVL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 4, 2020
Date Received
December 6, 2019
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 Inter-Med/Vista Dental Products

  • K193357 — V-Mix (October 23, 2020)
  • K193409 — Vista Rinse, Vista Rinse Plus (September 9, 2020)
  • K193447 — Vista Dyes (March 11, 2020)
  • K190220 — Vista FS, Vista FS Liquid (June 10, 2019)
  • K170101 — Valiant Curing Light (June 8, 2017)

Other clearances for product code MVL

  • 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)
  • K190220 — Vista FS, Vista FS Liquid (June 10, 2019)
  • K171577 — Smartcord, Smartcord X (May 3, 2018)
  • K162662 — GingiDent Gingival Retraction Paste (October 20, 2017)
  • K162948 — Styptin, Hemogin-L, Hemodettes, and GingiGEL Aluminum Chloride Impregnated Retra (August 8, 2017)