Cleared Traditional

GATES GLIDDEN DRILLS

K905418 · The Hygenic Corp. · Dental
Jul 1991
Decision
233d
Days
Class 1
Risk

About This 510(k) Submission

K905418 is an FDA 510(k) clearance for the GATES GLIDDEN DRILLS, a Drill, Dental, Intraoral (Class I — General Controls, product code DZA), submitted by The Hygenic Corp. (Akron, US). The FDA issued a Cleared decision on July 25, 1991, 233 days after receiving the submission on December 4, 1990. This device falls under the Dental review panel. Regulated under 21 CFR 872.4130.

Submission Details

510(k) Number K905418 FDA.gov
FDA Decision Cleared SESE
Date Received December 04, 1990
Decision Date July 25, 1991
Days to Decision 233 days
Submission Type Traditional
Review Panel Dental (DE)
Summary —

Device Classification

Product Code DZA — Drill, Dental, Intraoral
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4130

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