Cleared Traditional

DENDIA WERK BURS AND CUTTING DISCS

K901967 · Micro-Aire Surgical Instruments, Inc. · Dental
Jul 1990
Decision
73d
Days
Class 1
Risk

About This 510(k) Submission

K901967 is an FDA 510(k) clearance for the DENDIA WERK BURS AND CUTTING DISCS, a Instrument, Diamond, Dental (Class I — General Controls, product code DZP), submitted by Micro-Aire Surgical Instruments, Inc. (Valencia, US). The FDA issued a Cleared decision on July 13, 1990, 73 days after receiving the submission on May 1, 1990. This device falls under the Dental review panel. Regulated under 21 CFR 872.4535.

Submission Details

510(k) Number K901967 FDA.gov
FDA Decision Cleared SESE
Date Received May 01, 1990
Decision Date July 13, 1990
Days to Decision 73 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code DZP — Instrument, Diamond, Dental
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4535

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