Cleared Traditional

K152274 - MSCB-001 (FDA 510(k) Clearance)

K152274 · GC America, Inc. · Dental device

Mar 2016

Decision

226d

Days

Class 2

Risk

K152274 is an FDA 510(k) clearance for the MSCB-001. This device is classified as a Powder, Porcelain (Class II - Special Controls, product code EIH).

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on March 25, 2016, 226 days after receiving the submission on August 12, 2015.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6660.

Submission Details

510(k) Number	K152274 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 12, 2015
Decision Date	March 25, 2016
Days to Decision	226 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF