Cleared Traditional

K925378 - STERI-SOL SOLUTION, MODIFICATION

K925378 is an FDA 510(k) clearance for STERI-SOL SOLUTION, manufactured by Anodia Systems. The device is a Class 1 Dental device with product code EFB cleared through the Traditional 510(k) pathway after a 289-day FDA review.

K925378 · Anodia Systems · Dental device
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Jul 1993
Decision
289d
Days
Class 1
Risk

K925378 is an FDA 510(k) clearance for the STERI-SOL SOLUTION, MODIFICATION. Classified as Handpiece, Air-powered, Dental (product code EFB), Class I - General Controls.

Submitted by Anodia Systems (Danville, US). The FDA issued a Cleared decision on July 22, 1993 after a review of 289 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4200 - 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 Anodia Systems devices

FDA 510(k) Submission Details - K925378

510(k) Number K925378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1992
Decision Date July 22, 1993
Days to Decision 289 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
162d slower than avg
Panel avg: 127d · This submission: 289d
Pathway characteristics
Predicate-based equivalence.

EFB Device Classification - Class 1, General Controls

Product Code EFB Handpiece, Air-powered, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4200
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 - EFB Handpiece, Air-powered, Dental

All 156
Devices cleared under the same product code (EFB) and FDA review panel - the closest regulatory comparables to K925378.
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