Cleared Traditional

DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR (K940769) - FDA 510(k) Clearance

Class I Dental device.

K940769 · Terraflex · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1994
Decision
180d
Days
Class 1
Risk

K940769 is an FDA 510(k) clearance for the DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR. Classified as Mouthpiece, Saliva Ejector (product code DYN), Class I - General Controls.

Submitted by Terraflex (Efrat 90962, IL). The FDA issued a Cleared decision on August 17, 1994 after a review of 180 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Terraflex devices

Submission Details

510(k) Number K940769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d slower than avg
Panel avg: 127d · This submission: 180d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code DYN Mouthpiece, Saliva Ejector
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.