SMARTBURS— 510(k) K080687

Name: FDA 510(k) clearance K080687
Creator: U.S. Food and Drug Administration
Published: 2008-06-20

Substantially Equivalent

S.S. White Burs, Inc.

FDA 510(k) clearance K080687 for SMARTBURS, Substantially Equivalent on 2008-06-20. Applicant: S.S. White Burs, Inc.. Device class: 1.

Clearance details

Applicant: S.S. White Burs, Inc.
Product code: Code EJL
Device class: Class 1
Regulation: 21 CFR 872.3240
Advisory panel: Dental
Date received: 2008-03-11
Decision date: 2008-06-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EJL

view all

K071352 — CERADRILL2007-06-29
K061383 — BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS2006-08-03
K943273 — TRI HAWK BUR, FG BUR1994-08-01
K926205 — MONOSTERYL1994-02-10
K923883 — DENTAL OR SURGICAL BUR1993-07-27

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.