Cleared Traditional

V-Print splint

K201091 · Voco GmbH · Dental
Nov 2020
Decision
197d
Days
—
Risk

About This 510(k) Submission

K201091 is an FDA 510(k) clearance for the V-Print splint, a Mouthguard, Prescription, submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on November 6, 2020, 197 days after receiving the submission on April 23, 2020. This device falls under the Dental review panel.

Submission Details

510(k) Number K201091 FDA.gov
FDA Decision Cleared SESE
Date Received April 23, 2020
Decision Date November 06, 2020
Days to Decision 197 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code MQC — Mouthguard, Prescription
Device Class —