Cleared Traditional

K131504 - UNIVERSAL OPAQUE (FDA 510(k) Clearance)

K131504 · Shofu Dental Corporation · Dental device

Jul 2013

Decision

53d

Days

Class 2

Risk

K131504 is an FDA 510(k) clearance for the UNIVERSAL OPAQUE. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).

Submitted by Shofu Dental Corporation (San Marcos, US). The FDA issued a Cleared decision on July 16, 2013, 53 days after receiving the submission on May 24, 2013.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3690.

Submission Details

510(k) Number	K131504 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 24, 2013
Decision Date	July 16, 2013
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement