Cleared Traditional

K091647 - INJECTAFIL
(FDA 510(k) Clearance)

K091647 · Apex Dental Materials, Inc. · Dental device

Sep 2009

Decision

104d

Days

Class 2

Risk

K091647 is an FDA 510(k) clearance for the INJECTAFIL. This device is classified as a Material, Tooth Shade, Resin (Class II - Special Controls, product code EBF).

Submitted by Apex Dental Materials, Inc. (Lake Zurich, US). The FDA issued a Cleared decision on September 21, 2009, 104 days after receiving the submission on June 9, 2009.

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

Submission Details

510(k) Number	K091647 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 09, 2009
Decision Date	September 21, 2009
Days to Decision	104 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement