Cleared Traditional

K901806 - SUCTION ORA-SWAB(R) BRUSH KIT (FDA 510(k) Clearance)

Class I Dental device.

K901806 · Sage Products, Inc. · Dental device
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Aug 1990
Decision
117d
Days
Class 1
Risk

K901806 is an FDA 510(k) clearance for the SUCTION ORA-SWAB(R) BRUSH KIT. Classified as Unit, Operative Dental (product code EIA), Class I - General Controls.

Submitted by Sage Products, Inc. (Cary, US). The FDA issued a Cleared decision on August 15, 1990 after a review of 117 days - within the typical 510(k) review window.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6640 - 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 Sage Products, Inc. devices

Submission Details

510(k) Number K901806 FDA.gov
FDA Decision Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received April 20, 1990
Decision Date August 15, 1990
Days to Decision 117 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
10d faster than avg
Panel avg: 127d · This submission: 117d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code EIA Unit, Operative Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.6640
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.

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