Cleared Traditional

Prime&Bond Elect Universal Dental Adhesive

K151619 · Dentsply International, Inc. · Dental
Oct 2015
Decision
136d
Days
Class 2
Risk

About This 510(k) Submission

K151619 is an FDA 510(k) clearance for the Prime&Bond Elect Universal Dental Adhesive, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Dentsply International, Inc. (York, US). The FDA issued a Cleared decision on October 30, 2015, 136 days after receiving the submission on June 16, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K151619 FDA.gov
FDA Decision Cleared SESE
Date Received June 16, 2015
Decision Date October 30, 2015
Days to Decision 136 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