Cleared Traditional

GLENROE ELASTIBITE STIMULATOR

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

About This 510(k) Submission

K924351 is an FDA 510(k) clearance for the GLENROE ELASTIBITE STIMULATOR, a Positioner, Tooth, Preformed (Class I — General Controls, product code KMY), submitted by Glenroe Technologies (Bradenton, US). The FDA issued a Cleared decision on January 6, 1994, 496 days after receiving the submission on August 28, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.5525.

Submission Details

510(k) Number K924351 FDA.gov
FDA Decision Cleared 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

Device Classification

Product Code KMY — Positioner, Tooth, Preformed
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.5525

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