Cleared Traditional

K151700 - BEAUTIFIL II Gingiva (FDA 510(k) Clearance)

K151700 · Shofu Dental Corporation · Dental device

Mar 2016

Decision

252d

Days

Class 2

Risk

K151700 is an FDA 510(k) clearance for the BEAUTIFIL II Gingiva. 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 March 2, 2016, 252 days after receiving the submission on June 24, 2015.

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

Submission Details

510(k) Number	K151700 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 24, 2015
Decision Date	March 02, 2016
Days to Decision	252 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement