Cleared Traditional

K083796 - MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT

K083796 is an FDA 510(k) clearance for MILTEX ASPIRATING SYRINGE, manufactured by Miltex, Inc.. The device is a Class 2 Dental device with product code EJI cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K083796 · Miltex, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2009
Decision
77d
Days
Class 2
Risk

K083796 is an FDA 510(k) clearance for the MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPI.... Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Miltex, Inc. (York, US). The FDA issued a Cleared decision on March 9, 2009 after a review of 77 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.

View all Miltex, Inc. devices

FDA 510(k) Submission Details - K083796

510(k) Number K083796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 2008
Decision Date March 09, 2009
Days to Decision 77 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
51d faster than avg
Panel avg: 128d · This submission: 77d
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 25
Devices cleared under the same product code (EJI) and FDA review panel - the closest regulatory comparables to K083796.
ANESTHESIA INJECTION TOOL SET
K113247 · Ki Works Co., Ltd. · Mar 2012
MORPHEUS
K082249 · Meibach Tech Ltda · Dec 2009
ASPIRATING SYRINGE, NON-ASPIRATING SYRINGE
K092943 · Arnold Tuber Industries · Dec 2009
DENJECTOR
K081694 · Dxm Co., Ltd. · Sep 2008
COMPUDENT STA
K061904 · Milestone Scientific, Inc. · Aug 2006
MIRAMATIC SAFE SYRINGE SYSTEM
K043322 · Hager Worldwide, Inc. · Jul 2005