510(k) K922437— HANDPIECE MODELS MS-350, RS-350; AIR MOTOR N-270

Substantially Equivalent

Dabi-Atlante America Corp.

Clearance details

Applicant: Dabi-Atlante America Corp.
Product code: Code EFB
Advisory panel: Dental
Date received: 1992-05-22
Decision date: 1992-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tampa, FL, US

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.