Cleared Traditional

Registrado Scan

K171815 · Voco GmbH · Dental
Nov 2017
Decision
149d
Days
Class 2
Risk

About This 510(k) Submission

K171815 is an FDA 510(k) clearance for the Registrado Scan, a Material, Tooth Shade, Resin (Class II — Special Controls, product code EBF), submitted by Voco GmbH (Cuxhaven, DE). The FDA issued a Cleared decision on November 15, 2017, 149 days after receiving the submission on June 19, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number K171815 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 2017
Decision Date November 15, 2017
Days to Decision 149 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBF — Material, Tooth Shade, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3690