Cleared Traditional

K833598 - LEBLOND DIAMOND DENTAL BUR

K833598 is an FDA 510(k) clearance for LEBLOND DIAMOND DENTAL BUR, manufactured by A & M Instruments, Inc.. The device is a Class 1 Dental device with product code EJL cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K833598 · A & M Instruments, Inc. · Dental device
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Dec 1983
Decision
78d
Days
Class 1
Risk

K833598 is an FDA 510(k) clearance for the LEBLOND DIAMOND DENTAL BUR. Classified as Bur, Dental (product code EJL), Class I - General Controls.

Submitted by A & M Instruments, Inc. (Walker, US). The FDA issued a Cleared decision on December 29, 1983 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.3240 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all A & M Instruments, Inc. devices

FDA 510(k) Submission Details - K833598

510(k) Number K833598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1983
Decision Date December 29, 1983
Days to Decision 78 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 128d · This submission: 78d
Pathway characteristics
Predicate-based equivalence.

EJL Device Classification - Class 1, General Controls

Product Code EJL Bur, Dental
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 872.3240
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 - EJL Bur, Dental

All 8
Devices cleared under the same product code (EJL) and FDA review panel - the closest regulatory comparables to K833598.
BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS
K061383 · B.T.I. Biotechnology Institute, Sl. · Aug 2006
DIAMONDS BURS-COMPOSIT FINISHING
K854690 · Almore Intl., Inc. · Mar 1986
DIAMOND BURS-HANDPIECE
K854691 · Almore Intl., Inc. · Mar 1986
DENTAL INSTRUMENTS
K823314 · Miltex, Inc. · Nov 1982
SUPERFINE DIAMONDS
K771214 · Den-Mat Corp. · Jul 1977
CUTTER TUNGSTEN CARBIDE BURS
K770469 · Cutter Laboratories, Inc. · Mar 1977