Cleared Traditional

SUCTION ORA-SWAB(R) BRUSH KIT

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

About This 510(k) Submission

K901806 is an FDA 510(k) clearance for the SUCTION ORA-SWAB(R) BRUSH KIT, a Unit, Operative Dental (Class I — General Controls, product code EIA), submitted by Sage Products, Inc. (Cary, US). The FDA issued a Cleared decision on August 15, 1990, 117 days after receiving the submission on April 20, 1990. This device falls under the Dental review panel. Regulated under 21 CFR 872.6640.

Submission Details

510(k) Number K901806 FDA.gov
FDA Decision Cleared SESD
Date Received April 20, 1990
Decision Date August 15, 1990
Days to Decision 117 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EIA — Unit, Operative Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6640

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