Cleared Traditional

K043322 - MIRAMATIC SAFE SYRINGE SYSTEM

K043322 is an FDA 510(k) clearance for MIRAMATIC SAFE SYRINGE SYSTEM, manufactured by Hager Worldwide, Inc.. The device is a Class 2 Dental device with product code EJI cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K043322 · Hager Worldwide, Inc. · Dental device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2005
Decision
231d
Days
Class 2
Risk

K043322 is an FDA 510(k) clearance for the MIRAMATIC SAFE SYRINGE SYSTEM. Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Hager Worldwide, Inc. (Andover, US). The FDA issued a Cleared decision on July 21, 2005 after a review of 231 days - an extended review 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: 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 - K043322

510(k) Number K043322 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 02, 2004
Decision Date July 21, 2005
Days to Decision 231 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
103d slower than avg
Panel avg: 128d · This submission: 231d
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 41
Devices cleared under the same product code (EJI) and FDA review panel - the closest regulatory comparables to K043322.
MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT
K083796 · Miltex, Inc. · Mar 2009
DENJECTOR
K081694 · Dxm Co., Ltd. · Sep 2008
COMPUDENT STA
K061904 · Milestone Scientific, Inc. · Aug 2006
EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES
K040671 · Anthogyr · Dec 2004
SAFETYWAND DISPOSABLE HANDPIECE
K023722 · Spintech, Inc. · Sep 2003
SAFESTEP SAFETY DENTAL CARTRIDGE INJECTOR, MODEL 33-00000-1
K022959 · MDC Research , Ltd. · Feb 2003
K043322 · MIRAMATIC SAFE SYRINGE SYSTEM
Download PDF FDA Summary Hager Worldwide, Inc.