Cleared Traditional

K081694 - DENJECTOR

K081694 is an FDA 510(k) clearance for DENJECTOR, manufactured by Dxm Co., Ltd.. The device is a Class 2 Dental device with product code EJI cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K081694 · Dxm Co., Ltd. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2008
Decision
87d
Days
Class 2
Risk

K081694 is an FDA 510(k) clearance for the DENJECTOR. Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Dxm Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on September 12, 2008 after a review of 87 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K081694

510(k) Number K081694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 2008
Decision Date September 12, 2008
Days to Decision 87 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
41d faster than avg
Panel avg: 128d · This submission: 87d
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 43
Devices cleared under the same product code (EJI) and FDA review panel - the closest regulatory comparables to K081694.
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
COMPUDENT STA
K061904 · Milestone Scientific, Inc. · Aug 2006
MIRAMATIC SAFE SYRINGE SYSTEM
K043322 · Hager Worldwide, Inc. · Jul 2005
EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES
K040671 · Anthogyr · Dec 2004
K081694 · DENJECTOR
Download PDF FDA Summary Dxm Co., Ltd.