Cleared Traditional

V-Print c&b temp

K231591 · Voco GmbH · Dental

Jul 2023

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K231591 is an FDA 510(k) clearance for the V-Print c&b temp, a Crown And Bridge, Long-term Temporary, Resin (Class II — Special Controls, product code POW), submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on July 31, 2023, 60 days after receiving the submission on June 1, 2023. This device falls under the Dental review panel. Regulated under 21 CFR 872.3770.

Submission Details

510(k) Number	K231591 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 01, 2023
Decision Date	July 31, 2023
Days to Decision	60 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement

Device Classification

Product Code	POW — Crown And Bridge, Long-term Temporary, Resin
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 872.3770
Definition	For The Fabrication Of Long-term Temporary Crowns And Bridges