510(k) K170261— Premium Plus Prophy Air Motor

Substantially Equivalent

Premium Plus International Limited

Clearance details

Applicant: Premium Plus International Limited
Product code: Code EFB
Advisory panel: Dental
Date received: 2017-01-27
Decision date: 2017-10-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Hong Kong, CN

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.