Cleared Traditional

K150727 - ESTECEM (FDA 510(k) Clearance)

K150727 · Tokuyama Dental Corporation · Dental device

Jun 2015

Decision

89d

Days

Class 2

Risk

K150727 is an FDA 510(k) clearance for the ESTECEM. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by Tokuyama Dental Corporation (Tokyo, JP). The FDA issued a Cleared decision on June 17, 2015, 89 days after receiving the submission on March 20, 2015.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number	K150727 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 20, 2015
Decision Date	June 17, 2015
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF