Cleared Traditional

K080687 - SMARTBURS

K080687 is an FDA 510(k) clearance for SMARTBURS, manufactured by S.S. White Burs, Inc.. The device is a Class 1 Dental device with product code EJL cleared through the Traditional 510(k) pathway after a 101-day FDA review.

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

FDA 510(k) Submission Details - K080687

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.

EJL Device Classification - Class 1, General Controls

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.