Home / 510(k) Clearances / K113839

510(k) K113839

RETRACT GINGIVAL RETRACTION/HEMOSTATIC PASTE by Parkell, Inc. — Product Code MVL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 2012
Date Received
December 28, 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 Parkell, Inc.

  • K243254 — Parkell Pit and Fissure Sealant (August 8, 2025)
  • K210259 — Parkell Self-Adhesive Cement (January 20, 2022)
  • K191103 — Parkell Desensitizer Gel (November 22, 2019)
  • K190930 — SmarTemp X1 (September 5, 2019)
  • K182296 — HyperFil-LV (December 14, 2018)
  • K172176 — Parkell Universal Adhesive (November 21, 2017)
  • K151518 — BRUSH&BOND PLUS (September 18, 2015)
  • K142848 — EAZY PRIMER (February 24, 2015)
  • K132115 — ABSOLUTE DENTIN 2 (June 25, 2014)
  • K101044 — RETRIEVE IMPLANT CEMENT (June 10, 2010)

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)
  • 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)