Cleared Traditional

K894930 - DENTEC 4000

K894930 is an FDA 510(k) clearance for DENTEC 4000, manufactured by Dentec, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code ETN cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K894930 · Dentec, Inc. · Ear, Nose, Throat device
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Mar 1990
Decision
237d
Days
Class 2
Risk

K894930 is an FDA 510(k) clearance for the DENTEC 4000. Classified as Stimulator, Nerve (product code ETN), Class II - Special Controls.

Submitted by Dentec, Inc. (Washington, D.C., US). The FDA issued a Cleared decision on March 27, 1990 after a review of 237 days - an extended review cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.1820 - the FDA ear, nose and throat device 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 Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

View all Dentec, Inc. devices

FDA 510(k) Submission Details - K894930

510(k) Number K894930 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1989
Decision Date March 27, 1990
Days to Decision 237 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
148d slower than avg
Panel avg: 89d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ETN Device Classification - Class 2, Special Controls

Product Code ETN Stimulator, Nerve
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 874.1820
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 Ear, Nose, Throat devices follow this clearance model.

Regulatory Peers - ETN Stimulator, Nerve

All 42
Devices cleared under the same product code (ETN) and FDA review panel - the closest regulatory comparables to K894930.
STIMULATING SURGICAL INSTRUMENTS
K934733 · Smith & Nephew Richards, Inc. · Jul 1994
R AND D BATTERIES, INC. PART NOS. 5038 & 5347
K933491 · R & D Batteries, Inc. · Nov 1993
NERVE LOCATOR/STIMULATOR
K905045 · Aaron Medical Industries · Mar 1991
RESUBMITTED JUNIPER T.M. JOINT DISTRACTION FORCEPS
K881757 · Downs Surgical , Ltd. · Jul 1988
MONTGOMERY NERVE STIMULATOR
K880720 · Boston Medical Products, Inc. · May 1988
MODEL 6110C OTOPHOR
K870272 · Life-Tech Intl., Inc. · Aug 1987