Cleared Traditional

K941915 - ORAL STEEL CARTRIDGE SYRINGE

K941915 is an FDA 510(k) clearance for ORAL STEEL CARTRIDGE SYRINGE, manufactured by Robert W. Bauer & Assoc., Inc.. The device is a Class 2 Dental device with product code EJI cleared through the Traditional 510(k) pathway after a 282-day FDA review.

K941915 · Robert W. Bauer & Assoc., Inc. · Dental device
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Jan 1995
Decision
282d
Days
Class 2
Risk

K941915 is an FDA 510(k) clearance for the ORAL STEEL CARTRIDGE SYRINGE. Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Robert W. Bauer & Assoc., Inc. (Chicago, US). The FDA issued a Cleared decision on January 26, 1995 after a review of 282 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 Robert W. Bauer & Assoc., Inc. devices

FDA 510(k) Submission Details - K941915

510(k) Number K941915 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 1994
Decision Date January 26, 1995
Days to Decision 282 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
155d slower than avg
Panel avg: 127d · This submission: 282d
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 K941915.
THE WAND
K961648 · Spintech, Inc. · Jul 1996
DENTALOGIC
K960270 · Protecs Syringes International Corp. · Mar 1996
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
BEACH ANESTHETIC SYRINGE CARTR. TYPE
K821782 · Pacific Dental Corp. · Jul 1982