Cleared Traditional

K830524 - HENKE JECT PRESSURE SYRINGE

K830524 is an FDA 510(k) clearance for HENKE JECT PRESSURE SYRINGE, manufactured by Smith & Nephew, Mpl Division. The device is a Class 2 Dental device with product code EJI cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K830524 · Smith & Nephew, Mpl Division · Dental device
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Mar 1983
Decision
35d
Days
Class 2
Risk

K830524 is an FDA 510(k) clearance for the HENKE JECT PRESSURE SYRINGE. Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Smith & Nephew, Mpl Division (Walker, US). The FDA issued a Cleared decision on March 24, 1983 after a review of 35 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 Smith & Nephew, Mpl Division devices

FDA 510(k) Submission Details - K830524

510(k) Number K830524 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 17, 1983
Decision Date March 24, 1983
Days to Decision 35 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 127d · This submission: 35d
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 24
Devices cleared under the same product code (EJI) and FDA review panel - the closest regulatory comparables to K830524.
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
MULTI-PURPOSE DENTAL SYRINGE
K811831 · Centrix, Inc. · Sep 1981
MONOJECT PLASTIC DENTAL INJ. SYRINGE
K792541 · Sherwood Medical Co. · Feb 1980