Cleared Traditional

K864294 - HENKE-JECT PRESSURE SYRINGE (MODIFICATION) (FDA 510(k) Clearance)

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

K864294 · Smith & Nephew, Inc. · Dental device
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Nov 1987
Decision
369d
Days
Class 2
Risk

K864294 is an FDA 510(k) clearance for the HENKE-JECT PRESSURE SYRINGE (MODIFICATION). Classified as Injector, Jet, Mechanical-powered (product code EGM), Class II - Special Controls.

Submitted by Smith & Nephew, Inc. (Chicago, US). The FDA issued a Cleared decision on November 4, 1987 after a review of 369 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4475 - 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. Elevated predicate reliance profile. 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 Smith & Nephew, Inc. devices

Submission Details

510(k) Number K864294 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 31, 1986
Decision Date November 04, 1987
Days to Decision 369 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
242d slower than avg
Panel avg: 127d · This submission: 369d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EGM Injector, Jet, Mechanical-powered
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.4475
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.