Cleared Traditional

K940769 - DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR

K940769 is an FDA 510(k) clearance for DENTFLEX DISPLOSABLE DENTAL SALIVA EJECTOR, manufactured by Terraflex. The device is a Class 1 Dental device with product code DYN cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K940769 · Terraflex · Dental device
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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

FDA 510(k) Submission Details - K940769

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.

DYN Device Classification - Class 1, General Controls

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.