Cleared Traditional

HC Primer

K161891 · Shofu Dental Corporation · Dental
Nov 2016
Decision
133d
Days
Class 2
Risk

About This 510(k) Submission

K161891 is an FDA 510(k) clearance for the HC Primer, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on November 21, 2016, 133 days after receiving the submission on July 11, 2016. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K161891 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 2016
Decision Date November 21, 2016
Days to Decision 133 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