Cleared Traditional

K923757 - DENTAL DIAMOND DRILLS

K923757 is an FDA 510(k) clearance for DENTAL DIAMOND DRILLS, manufactured by Alpha Industrializacao DE Metais Ltda.. The device is a Class 1 Dental device with product code DZP cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K923757 · Alpha Industrializacao DE Metais Ltda. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K923757

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.

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 K923757.
BLUWHITE DIAMOND DENTAL BURS MODIFIED
K120037 · Beavers Dental, Div. Sybron Canada, Ltd. · Apr 2012
DENDIA WERK BURS AND CUTTING DISCS
K901967 · Micro-Aire Surgical Instruments, Inc. · Jul 1990
HYBRID POINTS
K854347 · Shofu Dental Corp. · Dec 1985
GINGI CURETTAGE DIAMOND POINTS
K832856 · Shofu Dental Corp. · Oct 1983
SUMMA DISK
K833038 · Shofu Dental Corp. · Oct 1983
TPE DIAMOND POINTS
K832855 · Shofu Dental Corp. · Sep 1983