Cleared Traditional

STECO-TITANMAGNETICS

K990979 · Steco-System-Technik GmbH & Cokg · Dental

Sep 1999

Decision

164d

Days

Class 1

Risk

About This 510(k) Submission

K990979 is an FDA 510(k) clearance for the STECO-TITANMAGNETICS, a Attachment, Precision, All (Class I — General Controls, product code EGG), submitted by Steco-System-Technik GmbH & Cokg (Wurzburg, Bavaria, DE). The FDA issued a Cleared decision on September 3, 1999, 164 days after receiving the submission on March 23, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.3165.

Submission Details

510(k) Number	K990979 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 23, 1999
Decision Date	September 03, 1999
Days to Decision	164 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement