Cleared Traditional

K130841 - SHOFU BLOCK HC (FDA 510(k) Clearance)

K130841 · Shofu Dental Corporation · Dental device

Sep 2013

Decision

169d

Days

Class 2

Risk

K130841 is an FDA 510(k) clearance for the SHOFU BLOCK HC. 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 September 11, 2013, 169 days after receiving the submission on March 26, 2013.

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

Submission Details

510(k) Number	K130841 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 26, 2013
Decision Date	September 11, 2013
Days to Decision	169 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement