Cleared Traditional

Gingi-Aid Gel

K211419 · Belport Company, Inc., Gingi-Pak · Dental

Jan 2022

Decision

248d

Days

—

Risk

About This 510(k) Submission

K211419 is an FDA 510(k) clearance for the Gingi-Aid Gel, a Cord, Retraction, submitted by Belport Company, Inc., Gingi-Pak (Camarillo, US). The FDA issued a Cleared decision on January 10, 2022, 248 days after receiving the submission on May 7, 2021. This device falls under the Dental review panel.

Submission Details

510(k) Number	K211419 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 07, 2021
Decision Date	January 10, 2022
Days to Decision	248 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF