Cleared Traditional

ORAD TOOTHBRUSH CLEANER (K895345) - FDA 510(k) Clearance

Class I Dental device.

K895345 · Orad, Inc. · Dental device
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Mar 1990
Decision
188d
Days
Class 1
Risk

K895345 is an FDA 510(k) clearance for the ORAD TOOTHBRUSH CLEANER. Classified as Cleanser, Denture, Over The Counter (product code EFT), Class I - General Controls.

Submitted by Orad, Inc. (Modesto, US). The FDA issued a Cleared decision on March 7, 1990 after a review of 188 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3520 - 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 Orad, Inc. devices

Submission Details

510(k) Number K895345 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 31, 1989
Decision Date March 07, 1990
Days to Decision 188 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d slower than avg
Panel avg: 127d · This submission: 188d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFT Cleanser, Denture, Over The Counter
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3520
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.