Cleared Traditional

K120037 - BLUWHITE DIAMOND DENTAL BURS MODIFIED

K120037 is an FDA 510(k) clearance for BLUWHITE DIAMOND DENTAL BURS MODIFIED, manufactured by Beavers Dental, Div. Sybron Canada, Ltd.. The device is a Class 1 Dental device with 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

FDA 510(k) Submission Details - K120037

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 127d · This submission: 106d
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 K120037.
DENDIA WERK BURS AND CUTTING DISCS
K901967 · Micro-Aire Surgical Instruments, Inc. · Jul 1990
HYBRID POINTS
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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