Cleared Traditional

K924351 - GLENROE ELASTIBITE STIMULATOR

K924351 is an FDA 510(k) clearance for GLENROE ELASTIBITE STIMULATOR, manufactured by Glenroe Technologies. The device is a Class 1 Dental device with product code KMY cleared through the Traditional 510(k) pathway after a 496-day FDA review.

K924351 · Glenroe Technologies · Dental device
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Jan 1994
Decision
496d
Days
Class 1
Risk

K924351 is an FDA 510(k) clearance for the GLENROE ELASTIBITE STIMULATOR. Classified as Positioner, Tooth, Preformed (product code KMY), Class I - General Controls.

Submitted by Glenroe Technologies (Bradenton, US). The FDA issued a Cleared decision on January 6, 1994 after a review of 496 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.5525 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Dental submissions.

FDA 510(k) Submission Details - K924351

510(k) Number K924351 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1992
Decision Date January 06, 1994
Days to Decision 496 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
368d slower than avg
Panel avg: 128d · This submission: 496d
Pathway characteristics
Predicate-based equivalence.

KMY Device Classification - Class 1, General Controls

Product Code KMY Positioner, Tooth, Preformed
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.5525
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KMY Positioner, Tooth, Preformed

All 7
Devices cleared under the same product code (KMY) and FDA review panel - the closest regulatory comparables to K924351.
NITE-GUIDE
K931615 · Ortho-Tain, Inc. · Apr 1995
DENT-O-CRYL ORTHODONTIC ACRYLIC
K942667 · Dentauraum, Inc. · Feb 1995
RELAX-O-GUARD
K925064 · Aquatemp Service Co., Inc. · Sep 1993
THE ORTHOTRAINER
K924975 · Myofunctional Research Corp. Pty. , Ltd. · Jul 1993
THE TMJ APPLIANCE
K924974 · Myofunctional Research Corp. Pty. , Ltd. · Jun 1993
PERFORMED TEMPLATE W/FRAGRANCE FOR TOOTH POSTIONER
K904128 · American Orthodontics · Nov 1990
K924351 · GLENROE ELASTIBITE STIMULATOR
Download PDF Glenroe Technologies