Cleared Traditional

ANESTHESIA INJECTION TOOL SET

K113247 · Ki Works Co., Ltd. · Dental

Mar 2012

Decision

146d

Days

Class 2

Risk

About This 510(k) Submission

K113247 is an FDA 510(k) clearance for the ANESTHESIA INJECTION TOOL SET, a Syringe, Cartridge (Class II — Special Controls, product code EJI), submitted by Ki Works Co., Ltd. (Yongsan-Dong, Daejeon, KR). The FDA issued a Cleared decision on March 27, 2012, 146 days after receiving the submission on November 2, 2011. This device falls under the Dental review panel. Regulated under 21 CFR 872.6770.

Submission Details

510(k) Number	K113247 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 02, 2011
Decision Date	March 27, 2012
Days to Decision	146 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF