Cleared Traditional

ELECTRO FLOSS (K930178) - FDA 510(k) Clearance

Class I Dental device.

K930178 · Arizona Implant Dentistry · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
196d
Days
Class 1
Risk

K930178 is an FDA 510(k) clearance for the ELECTRO FLOSS. Classified as Pick, Massaging (product code JET), Class I - General Controls.

Submitted by Arizona Implant Dentistry (Tempe, US). The FDA issued a Cleared decision on July 28, 1993 after a review of 196 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6650 - 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 Arizona Implant Dentistry devices

Submission Details

510(k) Number K930178 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1993
Decision Date July 28, 1993
Days to Decision 196 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d slower than avg
Panel avg: 127d · This submission: 196d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JET Pick, Massaging
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6650
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.