EXCEL CONTRA ANGLE HANDPIECE— 510(k) K061897

Name: FDA 510(k) clearance K061897
Creator: U.S. Food and Drug Administration
Published: 2007-02-14

Substantially Equivalent

Orthosource, Inc.

FDA 510(k) clearance K061897 for EXCEL CONTRA ANGLE HANDPIECE, Substantially Equivalent on 2007-02-14. Applicant: Orthosource, Inc.. Device class: 1.

Clearance details

Applicant: Orthosource, Inc.
Product code: Code EGS
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2006-07-03
Decision date: 2007-02-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: North Hollywood, CA, US

Download summary PDF View on FDA.gov ↗

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K061581 — EXCEL HIGH SPEED DENTAL HANDPIECE2006-08-16

Adverse events under product code EGS

product code EGS

Injury: 356
Malfunction: 759
Total: 1,115

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.