Cleared Traditional

K940908 - DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS

K940908 is an FDA 510(k) clearance for DUNHALL/OMNII INTERNATIONAL ROTARY DIAM..., manufactured by Dunhall Pharmaceuticals, Inc.. The device is a Class 1 Dental device with product code DZP cleared through the Traditional 510(k) pathway after a 186-day FDA review.

K940908 · Dunhall Pharmaceuticals, Inc. · Dental device
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Aug 1994
Decision
186d
Days
Class 1
Risk

K940908 is an FDA 510(k) clearance for the DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS. Classified as Instrument, Diamond, Dental (product code DZP), Class I - General Controls.

Submitted by Dunhall Pharmaceuticals, Inc. (Gravette, US). The FDA issued a Cleared decision on August 29, 1994 after a review of 186 days - an extended review cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.4535 - 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 Dunhall Pharmaceuticals, Inc. devices

FDA 510(k) Submission Details - K940908

510(k) Number K940908 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1994
Decision Date August 29, 1994
Days to Decision 186 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
59d slower than avg
Panel avg: 127d · This submission: 186d
Pathway characteristics
Predicate-based equivalence.

DZP Device Classification - Class 1, General Controls

Product Code DZP Instrument, Diamond, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.4535
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 - DZP Instrument, Diamond, Dental

Devices cleared under the same product code (DZP) and FDA review panel - the closest regulatory comparables to K940908.
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