Cleared Traditional

GLENROE ORTHO-SIL

K945535 · Glenroe Technologies · Dental
Jan 1995
Decision
74d
Days
Class 1
Risk

About This 510(k) Submission

K945535 is an FDA 510(k) clearance for the GLENROE ORTHO-SIL, a Wax, Dental, Intraoral (Class I — General Controls, product code EGD), submitted by Glenroe Technologies (Bradenton, US). The FDA issued a Cleared decision on January 27, 1995, 74 days after receiving the submission on November 14, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.6890.

Submission Details

510(k) Number K945535 FDA.gov
FDA Decision Cleared SESE
Date Received November 14, 1994
Decision Date January 27, 1995
Days to Decision 74 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EGD — Wax, Dental, Intraoral
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6890