Cleared Traditional

K922307 - SHOWERFLOSS ORAL IRRIGATION UNIT

K922307 is an FDA 510(k) clearance for SHOWERFLOSS ORAL IRRIGATION UNIT, manufactured by Showerfloss, Inc.. The device is a Class 1 Dental device with product code EFS cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K922307 · Showerfloss, Inc. · Dental device
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Jun 1992
Decision
32d
Days
Class 1
Risk

K922307 is an FDA 510(k) clearance for the SHOWERFLOSS ORAL IRRIGATION UNIT. Classified as Unit, Oral Irrigation (product code EFS), Class I - General Controls.

Submitted by Showerfloss, Inc. (Bonita Springs, US). The FDA issued a Cleared decision on June 16, 1992 after a review of 32 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 Showerfloss, Inc. devices

FDA 510(k) Submission Details - K922307

510(k) Number K922307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 15, 1992
Decision Date June 16, 1992
Days to Decision 32 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
95d faster than avg
Panel avg: 127d · This submission: 32d
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.

Regulatory Peers - EFS Unit, Oral Irrigation

All 8
Devices cleared under the same product code (EFS) and FDA review panel - the closest regulatory comparables to K922307.
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K875132 · Dentsply Intl. · Feb 1988