Cleared Traditional

SHOFU MZ Primer Plus

K172106 · Shofu Dental Corporation · Dental
Aug 2017
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K172106 is an FDA 510(k) clearance for the SHOFU MZ Primer Plus, 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 August 31, 2017, 50 days after receiving the submission on July 12, 2017. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K172106 FDA.gov
FDA Decision Cleared SESE
Date Received July 12, 2017
Decision Date August 31, 2017
Days to Decision 50 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