Cleared Traditional

K945843 - SAFETY PLUS

K945843 is an FDA 510(k) clearance for SAFETY PLUS, manufactured by Arent Fox. The device is a Class 2 Dental device with product code EJI cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K945843 · Arent Fox · Dental device
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Jul 1995
Decision
223d
Days
Class 2
Risk

K945843 is an FDA 510(k) clearance for the SAFETY PLUS. Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Arent Fox (Washington, US). The FDA issued a Cleared decision on July 11, 1995 after a review of 223 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.

View all Arent Fox devices

FDA 510(k) Submission Details - K945843

510(k) Number K945843 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 1994
Decision Date July 11, 1995
Days to Decision 223 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
96d slower than avg
Panel avg: 127d · This submission: 223d
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 7
Devices cleared under the same product code (EJI) and FDA review panel - the closest regulatory comparables to K945843.
Miltex N-Tralig Intraligamentary Syringe
K142414 · Integra LifeSciences Corporation · Oct 2014
COMFORT CONTROL SYRINGE SYSTEM
K002387 · Dentsply Intl. · Sep 2000
EAGLE
K950309 · Aalba Dent, Inc. · Feb 1995
IMPULSE SEALER PRODUCT LINE
K943370 · Ultradent Products, Inc. · Oct 1994
CITOJECT CARTRIDGE SYRINGE
K842006 · Miles Laboratories, Inc. · Jul 1984
MULTI-PURPOSE DENTAL SYRINGE
K811831 · Centrix, Inc. · Sep 1981