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510(k) K171577

Smartcord, Smartcord X by Eastdent Co., Ltd. — Product Code MVL

K171577 is an FDA 510(k) premarket notification submitted by Eastdent Co., Ltd. for the device "Smartcord, Smartcord X". The FDA issued a decision of Substantially Equivalent on May 3, 2018. The device falls under product code MVL (Cord, Retraction), a Class U device.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 2018
Date Received
May 30, 2017
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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  • 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)
  • K162662 — GingiDent Gingival Retraction Paste (October 20, 2017)

FDA data resources