Cleared Traditional

K844318 - ORAL IRRIGATION TIP

K844318 is an FDA 510(k) clearance for ORAL IRRIGATION TIP, manufactured by Pro Pulse, Inc.. The device is a Class 1 Dental device with product code EFS cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K844318 · Pro Pulse, Inc. · Dental device
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Nov 1984
Decision
17d
Days
Class 1
Risk

K844318 is an FDA 510(k) clearance for the ORAL IRRIGATION TIP. Classified as Unit, Oral Irrigation (product code EFS), Class I - General Controls.

Submitted by Pro Pulse, Inc. (Fort Collins, US). The FDA issued a Cleared decision on November 23, 1984 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6510 - 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 Pro Pulse, Inc. devices

FDA 510(k) Submission Details - K844318

510(k) Number K844318 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 06, 1984
Decision Date November 23, 1984
Days to Decision 17 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
111d faster than avg
Panel avg: 128d · This submission: 17d
Pathway characteristics
Predicate-based equivalence.

EFS Device Classification - Class 1, General Controls

Product Code EFS Unit, Oral Irrigation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6510
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.