K141183

Substantially Equivalent

EVO 500 SERIES HIGH SPEED HANDPIECES/TIGER 500/300/101 SERIES HIGH SPEED HANDPIECES

Applicant: Ttbio Corp.
Product code: EFB
Advisory panel: Dental
Date received: 2014-05-07
Decision date: 2015-02-27
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Taichung, Roc, TW

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.