Cleared Traditional

K160596 - BEAUTIFIL II LS (FDA 510(k) Clearance)

K160596 · Shofu Dental Corporation · Dental device

Jul 2016

Decision

147d

Days

Class 2

Risk

K160596 is an FDA 510(k) clearance for the BEAUTIFIL II LS. 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 27, 2016, 147 days after receiving the submission on March 2, 2016.

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

Submission Details

510(k) Number	K160596 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 02, 2016
Decision Date	July 27, 2016
Days to Decision	147 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement