Cleared Traditional

MICRO-AIRE HIGH SPEED DRILL (2910-000)

K894606 · Micro-Aire Surgical Instruments, Inc. · Dental
Oct 1989
Decision
85d
Days
Class 1
Risk

About This 510(k) Submission

K894606 is an FDA 510(k) clearance for the MICRO-AIRE HIGH SPEED DRILL (2910-000), a Handpiece, Air-powered, Dental (Class I — General Controls, product code EFB), submitted by Micro-Aire Surgical Instruments, Inc. (Valencia, US). The FDA issued a Cleared decision on October 13, 1989, 85 days after receiving the submission on July 20, 1989. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K894606 FDA.gov
FDA Decision Cleared SESE
Date Received July 20, 1989
Decision Date October 13, 1989
Days to Decision 85 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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