Cleared Traditional

Vista Clear

K193389 · Inter-Med/Vista Dental Products · Dental

Mar 2020

Decision

89d

Days

—

Risk

About This 510(k) Submission

K193389 is an FDA 510(k) clearance for the Vista Clear, a Cord, Retraction, submitted by Inter-Med/Vista Dental Products (Racine, US). The FDA issued a Cleared decision on March 4, 2020, 89 days after receiving the submission on December 6, 2019. This device falls under the Dental review panel.

Submission Details

510(k) Number	K193389 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 06, 2019
Decision Date	March 04, 2020
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF