Cleared Traditional

K091019 - SPEEDCEM (FDA 510(k) Clearance)

K091019 · Ivoclar Vivadent, Inc. · Dental device

Jun 2009

Decision

56d

Days

Class 2

Risk

K091019 is an FDA 510(k) clearance for the SPEEDCEM. This device is classified as a Cement, Dental (Class II - Special Controls, product code EMA).

Submitted by Ivoclar Vivadent, Inc. (Amherst, US). The FDA issued a Cleared decision on June 4, 2009, 56 days after receiving the submission on April 9, 2009.

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

Submission Details

510(k) Number	K091019 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 09, 2009
Decision Date	June 04, 2009
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement