Cleared Traditional

K880179 - BEAVERS' DENTAL DIAMOND INSTRUMENTS

K880179 is the FDA 510(k) clearance for BEAVERS' DENTAL DIAMOND INSTRUMENTS by Beavers Dental, Div. Sybron Canada, Ltd.. It is a Class 1 Dental device (product code DZP) cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K880179 · Beavers Dental, Div. Sybron Canada, Ltd. · Dental device
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Mar 1988
Decision
56d
Days
Class 1
Risk

K880179 is an FDA 510(k) clearance for the BEAVERS' DENTAL DIAMOND INSTRUMENTS. Classified as Instrument, Diamond, Dental (product code DZP), Class I - General Controls.

Submitted by Beavers Dental, Div. Sybron Canada, Ltd. (Washington, US). The FDA issued a Cleared decision on March 9, 1988 after a review of 56 days - a notably fast clearance 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: 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 Beavers Dental, Div. Sybron Canada, Ltd. devices

Submission Details

510(k) Number K880179 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 13, 1988
Decision Date March 09, 1988
Days to Decision 56 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 127d · This submission: 56d
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.

Regulatory Peers - DZP Instrument, Diamond, Dental

Devices cleared under the same product code (DZP) and FDA review panel - the closest regulatory comparables to K880179.
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