Cleared Traditional

K950309 - EAGLE

K950309 is the FDA 510(k) clearance for EAGLE by Aalba Dent, Inc.. It is a Class 2 Dental device (product code EJI) cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K950309 · Aalba Dent, Inc. · Dental device
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Feb 1995
Decision
22d
Days
Class 2
Risk

K950309 is an FDA 510(k) clearance for the EAGLE. Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Aalba Dent, Inc. (Fairfield, US). The FDA issued a Cleared decision on February 16, 1995 after a review of 22 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 Aalba Dent, Inc. devices

Submission Details

510(k) Number K950309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1995
Decision Date February 16, 1995
Days to Decision 22 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
105d faster than avg
Panel avg: 127d · This submission: 22d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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

Devices cleared under the same product code (EJI) and FDA review panel - the closest regulatory comparables to K950309.
Miltex N-Tralig Intraligamentary Syringe
K142414 · Integra LifeSciences Corporation · Oct 2014
COMFORT CONTROL SYRINGE SYSTEM
K002387 · Dentsply Intl. · Sep 2000
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
MONOJECT PLASTIC DENTAL INJ. SYRINGE
K792541 · Sherwood Medical Co. · Feb 1980