Cleared Traditional

BLUWHITE DIAMOND DENTAL BURS MODIFIED (K120037) - FDA 510(k) Clearance

Class I Dental device.

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.