Cleared Traditional

K921406 - SILICONT BUR BLOCK (FDA 510(k) Clearance)

Class I Dental device.

K921406 · Innovators, Inc. · Dental device
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Apr 1992
Decision
39d
Days
Class 1
Risk

K921406 is an FDA 510(k) clearance for the SILICONT BUR BLOCK. Classified as Bur, Dental (product code EJL), Class I - General Controls.

Submitted by Innovators, Inc. (Jefferson City, US). The FDA issued a Cleared decision on April 28, 1992 after a review of 39 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Innovators, Inc. devices

Submission Details

510(k) Number K921406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 1992
Decision Date April 28, 1992
Days to Decision 39 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
88d faster than avg
Panel avg: 127d · This submission: 39d
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.