Cleared Traditional

DAWN LOW SPEED HANDPIECE SYSTEM

K821484 · Young Dental Manufacturing Co. 1, LLC · Dental
Jun 1982
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K821484 is an FDA 510(k) clearance for the DAWN LOW SPEED HANDPIECE SYSTEM, a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by Young Dental Manufacturing Co. 1, LLC (Mchenry, US). The FDA issued a Cleared decision on June 9, 1982, 22 days after receiving the submission on May 18, 1982. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K821484 FDA.gov
FDA Decision Cleared SESE
Date Received May 18, 1982
Decision Date June 09, 1982
Days to Decision 22 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code EFB — Handpiece, Air-powered, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

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