Cleared Traditional

DENTAL OR SURGICAL BUR (K923883) - FDA 510(k) Clearance

Class I Dental device.

K923883 · Stratum Dental Technologies, Inc. · Dental device
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Jul 1993
Decision
357d
Days
Class 1
Risk

K923883 is an FDA 510(k) clearance for the DENTAL OR SURGICAL BUR. Classified as Bur, Dental (product code EJL), Class I - General Controls.

Submitted by Stratum Dental Technologies, Inc. (Las Vegas, US). The FDA issued a Cleared decision on July 27, 1993 after a review of 357 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Stratum Dental Technologies, Inc. devices

Submission Details

510(k) Number K923883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1992
Decision Date July 27, 1993
Days to Decision 357 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
230d slower than avg
Panel avg: 127d · This submission: 357d
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.