Cleared Traditional

DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR

K940769 · Terraflex · Dental
Aug 1994
Decision
180d
Days
Class 1
Risk

About This 510(k) Submission

K940769 is an FDA 510(k) clearance for the DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR, a Mouthpiece, Saliva Ejector (Class I — General Controls, product code DYN), submitted by Terraflex (Efrat 90962, IL). The FDA issued a Cleared decision on August 17, 1994, 180 days after receiving the submission on February 18, 1994. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K940769 FDA.gov
FDA Decision Cleared SESE
Date Received February 18, 1994
Decision Date August 17, 1994
Days to Decision 180 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