Cleared Traditional

DISPOSABLE SCREW TYPE PROPHY BRUSH

K900507 · Dentsply Intl. · Dental
Apr 1990
Decision
67d
Days
Class 1
Risk

About This 510(k) Submission

K900507 is an FDA 510(k) clearance for the DISPOSABLE SCREW TYPE PROPHY BRUSH, a Cup, Prophylaxis (Class I — General Controls, product code EHK), submitted by Dentsply Intl. (York, US). The FDA issued a Cleared decision on April 10, 1990, 67 days after receiving the submission on February 2, 1990. This device falls under the Dental review panel. Regulated under 21 CFR 872.6290.

Submission Details

510(k) Number K900507 FDA.gov
FDA Decision Cleared SESE
Date Received February 02, 1990
Decision Date April 10, 1990
Days to Decision 67 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EHK — Cup, Prophylaxis
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.6290