Cleared Traditional

CB BUR (K863097) - FDA 510(k) Clearance

Class I Dental device.

K863097 · Beavers Dental, Div. Sybron Canada, Ltd. · Dental device
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Aug 1986
Decision
12d
Days
Class 1
Risk

K863097 is an FDA 510(k) clearance for the CB BUR. Classified as Bur, Dental (product code EJL), Class I - General Controls.

Submitted by Beavers Dental, Div. Sybron Canada, Ltd. (Washington, US). The FDA issued a Cleared decision on August 26, 1986 after a review of 12 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 Beavers Dental, Div. Sybron Canada, Ltd. devices

Submission Details

510(k) Number K863097 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1986
Decision Date August 26, 1986
Days to Decision 12 days
Submission Type Traditional
Review Panel Dental (DE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 127d · This submission: 12d
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.