Cleared Traditional

K061664 - FORMCORE DC, MODEL 28-700100
(FDA 510(k) Clearance)

K061664 · J. Morita USA, Inc. · Dental device

Sep 2006

Decision

86d

Days

Class 2

Risk

K061664 is an FDA 510(k) clearance for the FORMCORE DC, MODEL 28-700100. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).

Submitted by J. Morita USA, Inc. (Irvine, US). The FDA issued a Cleared decision on September 8, 2006, 86 days after receiving the submission on June 14, 2006.

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

Submission Details

510(k) Number	K061664 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 14, 2006
Decision Date	September 08, 2006
Days to Decision	86 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement