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510(k) K162662

GingiDent Gingival Retraction Paste by Pac-Dent International, Inc. — Product Code MVL

K162662 is an FDA 510(k) premarket notification submitted by Pac-Dent International, Inc. for the device "GingiDent Gingival Retraction Paste". The FDA issued a decision of Substantially Equivalent on October 20, 2017. The device falls under product code MVL (Cord, Retraction), a Class U device. Pac-Dent International, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2017
Date Received
September 26, 2016
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 Pac-Dent International, Inc.

  • K160577 — PacEndo Chlorhexidine (July 25, 2016)
  • K151123 — Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film (March 3, 2016)
  • K153528 — PacEndo EDTA (February 1, 2016)
  • K151852 — PacEndo Sodium Hyprochlorite (November 10, 2015)
  • K151150 — Elements (July 28, 2015)
  • K141717 — PACSEAL PIT & FISSURE SEALANT (March 9, 2015)
  • K141422 — PROFLUORO FLUORIDE VARNISH (September 30, 2014)
  • K130672 — OPTIFLOW II FLOWABLE COMPOSITE, LC (August 13, 2013)

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