CROMAX HIGH SPEED TURBINE HANDPIECE— 510(k) K041755

Substantially Equivalent

J.R. Medical Technologies, Inc.

FDA 510(k) clearance K041755 for CROMAX HIGH SPEED TURBINE HANDPIECE, Substantially Equivalent on 2004-10-22. Applicant: J.R. Medical Technologies, Inc..

Clearance details

Applicant: J.R. Medical Technologies, Inc.
Product code: Code EFB
Advisory panel: Dental
Date received: 2004-06-29
Decision date: 2004-10-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

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Adverse events under product code EFB

product code EFB

Injury: 133
Malfunction: 562
Total: 695

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.