Cleared Traditional

SPEEDCEM

K091019 · Ivoclar Vivadent, Inc. · Dental
Jun 2009
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K091019 is an FDA 510(k) clearance for the SPEEDCEM, 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 review panel. Regulated under 21 CFR 872.3275.

Submission Details

510(k) Number K091019 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code EMA — Cement, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3275