Cleared Traditional

K113247 - ANESTHESIA INJECTION TOOL SET

K113247 is an FDA 510(k) clearance for ANESTHESIA INJECTION TOOL SET, manufactured by Ki Works Co., Ltd.. The device is a Class 2 Dental device with product code EJI cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K113247 · Ki Works Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2012
Decision
146d
Days
Class 2
Risk

K113247 is an FDA 510(k) clearance for the ANESTHESIA INJECTION TOOL SET. Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Ki Works Co., Ltd. (Yongsan-Dong, Daejeon, KR). The FDA issued a Cleared decision on March 27, 2012 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6770 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K113247

510(k) Number K113247 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 128d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EJI Device Classification - Class 2, Special Controls

Product Code EJI Syringe, Cartridge
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6770
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.

Regulatory Peers - EJI Syringe, Cartridge

All 36
Devices cleared under the same product code (EJI) and FDA review panel - the closest regulatory comparables to K113247.
LeEject 2 Dental Syringe and Needle System
K171254 · Advanced Technology and Capital, Inc. · Nov 2017
Miltex N-Tralig Intraligamentary Syringe
K142414 · Integra LifeSciences Corporation · Oct 2014
HU-FRIEDY DENTAL CARTRIDGE SYRINGE
K120659 · Hu-Friedy Mfg. Co., LLC · Nov 2012
MORPHEUS
K082249 · Meibach Tech Ltda · Dec 2009
ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE
K092943 · Arnold Tuber Industries · Dec 2009
MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT
K083796 · Miltex, Inc. · Mar 2009
K113247 · ANESTHESIA INJECTION TOOL SET
Download PDF FDA Summary Ki Works Co., Ltd.