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510(k) K150423

EXPAZEN by Produits Dentaires Pierre Rolland (Acteon Group) — Product Code MVL

K150423 is an FDA 510(k) premarket notification submitted by Produits Dentaires Pierre Rolland (Acteon Group) for the device "EXPAZEN". The FDA issued a decision of Substantially Equivalent on July 8, 2015. The device falls under product code MVL (Cord, Retraction), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 2015
Date Received
February 19, 2015
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

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  • 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