Cleared Traditional

Stasis Gel

K211420 · Belport Company, Inc., Gingi-Pak · Dental
Mar 2022
Decision
311d
Days
—
Risk

About This 510(k) Submission

K211420 is an FDA 510(k) clearance for the Stasis Gel, a Cord, Retraction, submitted by Belport Company, Inc., Gingi-Pak (Camarillo, US). The FDA issued a Cleared decision on March 14, 2022, 311 days after receiving the submission on May 7, 2021. This device falls under the Dental review panel.

Submission Details

510(k) Number K211420 FDA.gov
FDA Decision Cleared SESE
Date Received May 07, 2021
Decision Date March 14, 2022
Days to Decision 311 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code MVL — Cord, Retraction
Device Class —