Cleared Traditional

Adhese Universal DC, Cention Primer

K210804 · Ivoclar Vivadent, AG · Dental
Jun 2022
Decision
447d
Days
Class 2
Risk

About This 510(k) Submission

K210804 is an FDA 510(k) clearance for the Adhese Universal DC, Cention Primer, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Ivoclar Vivadent, AG (Schaan, LI). The FDA issued a Cleared decision on June 7, 2022, 447 days after receiving the submission on March 17, 2021. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K210804 FDA.gov
FDA Decision Cleared SESE
Date Received March 17, 2021
Decision Date June 07, 2022
Days to Decision 447 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KLE — Agent, Tooth Bonding, Resin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3200