Cleared Traditional

SMARTBURS (K080687) - FDA 510(k) Clearance

Class I Dental device.

K080687 · S.S. White Burs, Inc. · Dental device
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Jun 2008
Decision
101d
Days
Class 1
Risk

K080687 is an FDA 510(k) clearance for the SMARTBURS. Classified as Bur, Dental (product code EJL), Class I - General Controls.

Submitted by S.S. White Burs, Inc. (Lakewood, US). The FDA issued a Cleared decision on June 20, 2008 after a review of 101 days - within the typical 510(k) review window.

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: 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 S.S. White Burs, Inc. devices

Submission Details

510(k) Number K080687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 2008
Decision Date June 20, 2008
Days to Decision 101 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 127d · This submission: 101d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.