Cleared Traditional

PEAK Z

K131357 · Ultradent Products, Inc. · Dental
Sep 2013
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K131357 is an FDA 510(k) clearance for the PEAK Z, a Agent, Tooth Bonding, Resin (Class II — Special Controls, product code KLE), submitted by Ultradent Products, Inc. (South Jordan, US). The FDA issued a Cleared decision on September 6, 2013, 119 days after receiving the submission on May 10, 2013. This device falls under the Dental review panel. Regulated under 21 CFR 872.3200.

Submission Details

510(k) Number K131357 FDA.gov
FDA Decision Cleared SESE
Date Received May 10, 2013
Decision Date September 06, 2013
Days to Decision 119 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