Cleared Traditional

K180649 - BeautiCem Veneer Kit (FDA 510(k) Clearance)

K180649 · Shofu Dental Corporation · Dental device

Jun 2018

Decision

90d

Days

Class 2

Risk

K180649 is an FDA 510(k) clearance for the BeautiCem Veneer Kit. 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 June 11, 2018, 90 days after receiving the submission on March 13, 2018.

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

Submission Details

510(k) Number	K180649 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 13, 2018
Decision Date	June 11, 2018
Days to Decision	90 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement