CST61 HIGH SPEED TURBINE HANDPIECE— 510(k) K063110

Substantially Equivalent

Shanghai Dental Instrument Factory

FDA 510(k) clearance K063110 for CST61 HIGH SPEED TURBINE HANDPIECE, Substantially Equivalent on 2006-10-26. Applicant: Shanghai Dental Instrument Factory.

Clearance details

Applicant: Shanghai Dental Instrument Factory
Product code: Code EFB
Advisory panel: Dental
Date received: 2006-10-11
Decision date: 2006-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Roswell, GA, 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.