Cleared Traditional

K895345 - ORAD TOOTHBRUSH CLEANER

K895345 is an FDA 510(k) clearance for ORAD TOOTHBRUSH CLEANER, manufactured by Orad, Inc.. The device is a Class 1 Dental device with product code EFT cleared through the Traditional 510(k) pathway after a 188-day FDA review.

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

FDA 510(k) Submission Details - K895345

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.

EFT Device Classification - Class 1, General Controls

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.