Cleared Traditional

K091106 - EQUIA (FDA 510(k) Clearance)

K091106 · GC America, Inc. · Dental device

Jun 2009

Decision

62d

Days

Class 2

Risk

K091106 is an FDA 510(k) clearance for the EQUIA. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on June 17, 2009, 62 days after receiving the submission on April 16, 2009.

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

Submission Details

510(k) Number	K091106 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 16, 2009
Decision Date	June 17, 2009
Days to Decision	62 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement