Cleared Traditional

PREMIER CERAMIC PRIMER

K131212 · Premier Dental Products Co. · Dental
Aug 2013
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K131212 is an FDA 510(k) clearance for the PREMIER CERAMIC PRIMER, 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 August 26, 2013, 119 days after receiving the submission on April 29, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K131212 FDA.gov
FDA Decision Cleared SESE
Date Received April 29, 2013
Decision Date August 26, 2013
Days to Decision 119 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