Cleared Traditional

NoCord

K152826 · Centrix, Inc. · Dental
May 2016
Decision
241d
Days
Class 2
Risk

About This 510(k) Submission

K152826 is an FDA 510(k) clearance for the NoCord, a Material, Impression (Class II — Special Controls, product code ELW), submitted by Centrix, Inc. (Shelton, US). The FDA issued a Cleared decision on May 27, 2016, 241 days after receiving the submission on September 29, 2015. This device falls under the Dental review panel. Regulated under 21 CFR 872.3660.

Submission Details

510(k) Number K152826 FDA.gov
FDA Decision Cleared SESE
Date Received September 29, 2015
Decision Date May 27, 2016
Days to Decision 241 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code ELW — Material, Impression
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3660

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