CB BUR— 510(k) K863097

Name: FDA 510(k) clearance K863097
Creator: U.S. Food and Drug Administration
Published: 1986-08-26

Substantially Equivalent

Beavers Dental, Div. Sybron Canada, Ltd.

FDA 510(k) clearance K863097 for CB BUR, Substantially Equivalent on 1986-08-26. Applicant: Beavers Dental, Div. Sybron Canada, Ltd.. Device class: 1.

Clearance details

Applicant: Beavers Dental, Div. Sybron Canada, Ltd.
Product code: Code EJL
Device class: Class 1
Regulation: 21 CFR 872.3240
Advisory panel: Dental
Date received: 1986-08-14
Decision date: 1986-08-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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K120037 — BLUWHITE DIAMOND DENTAL BURS MODIFIED2012-04-20
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Adverse events under product code EJL

product code EJL

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.