Cleared Traditional

ORAL STEEL CARTRIDGE SYRINGE (K941915) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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.