DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125— 510(k) K041141

Substantially Equivalent

Dentsply Intl.

FDA 510(k) clearance K041141 for DENTSPLY CAVITRON JET WAVE AIR POLISHING PROPHYLAXIS SYSTEM, MODEL G125, Substantially Equivalent on 2004-06-16. Applicant: Dentsply Intl..

Clearance details

Applicant: Dentsply Intl.
Product code: Code EFB
Advisory panel: Dental
Date received: 2004-04-30
Decision date: 2004-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: York, PA, 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.