Cleared Traditional

K833426 - DOCTOR VELLETTE'S INJECTOR

K833426 is an FDA 510(k) clearance for DOCTOR VELLETTE'S INJECTOR, manufactured by Deproco, Inc.. The device is a Class 2 Dental device with product code EJI cleared through the Traditional 510(k) pathway after a 101-day FDA review.

K833426 · Deproco, Inc. · Dental device
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Jan 1984
Decision
101d
Days
Class 2
Risk

K833426 is an FDA 510(k) clearance for the DOCTOR VELLETTE'S INJECTOR. Classified as Syringe, Cartridge (product code EJI), Class II - Special Controls.

Submitted by Deproco, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 13, 1984 after a review of 101 days - within the typical 510(k) review window.

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 Deproco, Inc. devices

FDA 510(k) Submission Details - K833426

510(k) Number K833426 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 1983
Decision Date January 13, 1984
Days to Decision 101 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 128d · This submission: 101d
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 K833426.
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