Cleared Traditional

K120037 - BLUWHITE DIAMOND DENTAL BURS MODIFIED

K120037 is the FDA 510(k) clearance for BLUWHITE DIAMOND DENTAL BURS MODIFIED 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 106-day FDA review.

K120037 · Beavers Dental, Div. Sybron Canada, Ltd. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2012
Decision
106d
Days
Class 1
Risk

K120037 is an FDA 510(k) clearance for the BLUWHITE DIAMOND DENTAL BURS MODIFIED. Classified as Instrument, Diamond, Dental (product code DZP), Class I - General Controls.

Submitted by Beavers Dental, Div. Sybron Canada, Ltd. (Orange, US). The FDA issued a Cleared decision on April 20, 2012 after a review of 106 days - within the typical 510(k) review window.

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 Beavers Dental, Div. Sybron Canada, Ltd. devices

Submission Details

510(k) Number K120037 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 2012
Decision Date April 20, 2012
Days to Decision 106 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 127d · This submission: 106d
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 K120037.
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