Cleared Traditional

EJECTOR

K924211 · Glenroe Technologies · Dental
Mar 1993
Decision
223d
Days
Class 1
Risk

About This 510(k) Submission

K924211 is an FDA 510(k) clearance for the EJECTOR, a Mouthpiece, Saliva Ejector (Class I — General Controls, product code DYN), submitted by Glenroe Technologies (Bradenton, US). The FDA issued a Cleared decision on March 31, 1993, 223 days after receiving the submission on August 20, 1992. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K924211 FDA.gov
FDA Decision Cleared SESE
Date Received August 20, 1992
Decision Date March 31, 1993
Days to Decision 223 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code DYN — Mouthpiece, Saliva Ejector
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6640