Cleared Traditional

PREMIER ETCH

K141839 · Premier Dental Products Co. · Dental
Nov 2014
Decision
132d
Days
Class 2
Risk

About This 510(k) Submission

K141839 is an FDA 510(k) clearance for the PREMIER ETCH, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Premier Dental Products Co. (Plymouth Meeting, US). The FDA issued a Cleared decision on November 17, 2014, 132 days after receiving the submission on July 8, 2014. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K141839 FDA.gov
FDA Decision Cleared SESE
Date Received July 08, 2014
Decision Date November 17, 2014
Days to Decision 132 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

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