Cleared Traditional

visio.lign color, visio.lign shield

K240735 · Bredent GmbH & Co. KG · Dental
Dec 2024
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K240735 is an FDA 510(k) clearance for the visio.lign color, visio.lign shield, a Coating, Filling Material, Resin (Class II — Special Controls, product code EBD), submitted by Bredent GmbH & Co. KG (Senden, DE). The FDA issued a Cleared decision on December 12, 2024, 269 days after receiving the submission on March 18, 2024. This device falls under the Dental review panel. Regulated under 21 CFR 872.3310.

Submission Details

510(k) Number K240735 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 2024
Decision Date December 12, 2024
Days to Decision 269 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EBD — Coating, Filling Material, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3310