GLENROE ELASTIBITE STIMULATOR— 510(k) K924351

Name: FDA 510(k) clearance K924351
Creator: U.S. Food and Drug Administration
Published: 1994-01-06

Substantially Equivalent

Glenroe Technologies

FDA 510(k) clearance K924351 for GLENROE ELASTIBITE STIMULATOR, Substantially Equivalent on 1994-01-06. Applicant: Glenroe Technologies. Device class: 1.

Clearance details

Applicant: Glenroe Technologies
Product code: Code KMY
Device class: Class 1
Regulation: 21 CFR 872.5525
Advisory panel: Dental
Date received: 1992-08-28
Decision date: 1994-01-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bradenton, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KMY

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K931615 — NITE-GUIDE1995-04-14
K942667 — DENT-O-CRYL ORTHODONTIC ACRYLIC1995-02-13
K925064 — RELAX-O-GUARD1993-09-13
K924975 — THE ORTHOTRAINER1993-07-08
K924974 — THE TMJ APPLIANCE1993-06-23

More clearances from Glenroe Technologies

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K980053 — GLENROE CHAIN1998-02-24
K945535 — GLENROE ORTHO-SIL1995-01-27
K932920 — GLENROE PLASTIC BRACKET1993-08-24
K924140 — TUFF TIES1993-04-27
K924139 — GLENROE ORTHO SEPS1993-04-08

Adverse events under product code KMY

product code KMY

Injury: 1,457
Total: 1,457

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.