Cleared Traditional

EASY X-TRAC SYSTEM

K060691 · A. Titan Instruments, Inc. · Dental

Jun 2006

Decision

89d

Days

Class 1

Risk

About This 510(k) Submission

K060691 is an FDA 510(k) clearance for the EASY X-TRAC SYSTEM, a Forceps, Tooth Extractor, Surgical (Class I — General Controls, product code EMG), submitted by A. Titan Instruments, Inc. (Hamburg, US). The FDA issued a Cleared decision on June 12, 2006, 89 days after receiving the submission on March 15, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number	K060691 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 15, 2006
Decision Date	June 12, 2006
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF