Cleared Traditional

K905418 - GATES GLIDDEN DRILLS

K905418 is an FDA 510(k) clearance for GATES GLIDDEN DRILLS, manufactured by The Hygenic Corp.. The device is a Class 1 Dental device with product code DZA cleared through the Traditional 510(k) pathway after a 233-day FDA review.

K905418 · The Hygenic Corp. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1991
Decision
233d
Days
Class 1
Risk

K905418 is an FDA 510(k) clearance for the GATES GLIDDEN DRILLS. Classified as Drill, Dental, Intraoral (product code DZA), Class I - General Controls.

Submitted by The Hygenic Corp. (Akron, US). The FDA issued a Cleared decision on July 25, 1991 after a review of 233 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4130 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all The Hygenic Corp. devices

FDA 510(k) Submission Details - K905418

510(k) Number K905418 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1990
Decision Date July 25, 1991
Days to Decision 233 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
106d slower than avg
Panel avg: 127d · This submission: 233d
Pathway characteristics
Predicate-based equivalence.

DZA Device Classification - Class 1, General Controls

Product Code DZA Drill, Dental, Intraoral
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4130
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DZA Drill, Dental, Intraoral

Devices cleared under the same product code (DZA) and FDA review panel - the closest regulatory comparables to K905418.
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