Cleared Traditional

DENTAL DIAMOND DRILLS (K923757) - FDA 510(k) Clearance

Class I Dental device.

K923757 · Alpha Industrializacao DE Metais Ltda. · Dental device
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Mar 1993
Decision
231d
Days
Class 1
Risk

K923757 is an FDA 510(k) clearance for the DENTAL DIAMOND DRILLS. Classified as Instrument, Diamond, Dental (product code DZP), Class I - General Controls.

Submitted by Alpha Industrializacao DE Metais Ltda. (Taboso De Serra Brazil, BR). The FDA issued a Cleared decision on March 16, 1993 after a review of 231 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 Alpha Industrializacao DE Metais Ltda. devices

Submission Details

510(k) Number K923757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 28, 1992
Decision Date March 16, 1993
Days to Decision 231 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
104d slower than avg
Panel avg: 127d · This submission: 231d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.