Cleared Traditional

K861934 - SALIVA EJECTOR

K861934 is an FDA 510(k) clearance for SALIVA EJECTOR, manufactured by Carlisle Laboratories, Inc.. The device is a Class 1 Dental device with product code DYN cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K861934 · Carlisle Laboratories, Inc. · Dental device
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Jun 1986
Decision
20d
Days
Class 1
Risk

K861934 is an FDA 510(k) clearance for the SALIVA EJECTOR. Classified as Mouthpiece, Saliva Ejector (product code DYN), Class I - General Controls.

Submitted by Carlisle Laboratories, Inc. (Inwood, US). The FDA issued a Cleared decision on June 9, 1986 after a review of 20 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Carlisle Laboratories, Inc. devices

FDA 510(k) Submission Details - K861934

510(k) Number K861934 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1986
Decision Date June 09, 1986
Days to Decision 20 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
108d faster than avg
Panel avg: 128d · This submission: 20d
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.