Cleared Traditional

ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM (K901994) - FDA 510(k) Clearance

Class I Dental device.

K901994 · Rosofsky & Ross, Inc. · Dental device
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Jul 1990
Decision
90d
Days
Class 1
Risk

K901994 is an FDA 510(k) clearance for the ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM. Classified as Toothbrush, Manual (product code EFW), Class I - General Controls.

Submitted by Rosofsky & Ross, Inc. (Washington, US). The FDA issued a Cleared decision on July 31, 1990 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6855 - 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 Rosofsky & Ross, Inc. devices

Submission Details

510(k) Number K901994 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received May 02, 1990
Decision Date July 31, 1990
Days to Decision 90 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 127d · This submission: 90d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EFW Toothbrush, Manual
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6855
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.