Cleared Traditional

HYGOFLEX SALIVA-EJECTOR (K935758) - FDA 510(k) Clearance

Class I Dental device.

K935758 · J.H.Orsing AB · Dental device
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Mar 1994
Decision
115d
Days
Class 1
Risk

K935758 is an FDA 510(k) clearance for the HYGOFLEX SALIVA-EJECTOR. Classified as Mouthpiece, Saliva Ejector (product code DYN), Class I - General Controls.

Submitted by J.H.Orsing AB (Raa, SE). The FDA issued a Cleared decision on March 21, 1994 after a review of 115 days - within the typical 510(k) review window.

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 J.H.Orsing AB devices

Submission Details

510(k) Number K935758 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 26, 1993
Decision Date March 21, 1994
Days to Decision 115 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
12d faster than avg
Panel avg: 127d · This submission: 115d
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.