Cleared Traditional

Parkell Universal Adhesive

K172176 · Parkell, Inc. · Dental
Nov 2017
Decision
125d
Days
Class 2
Risk

About This 510(k) Submission

K172176 is an FDA 510(k) clearance for the Parkell Universal Adhesive, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Parkell, Inc. (Edgewood, US). The FDA issued a Cleared decision on November 21, 2017, 125 days after receiving the submission on July 19, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K172176 FDA.gov
FDA Decision Cleared SESE
Date Received July 19, 2017
Decision Date November 21, 2017
Days to Decision 125 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