K983168

Substantially Equivalent

AVANT HIGH SPEED HANDPIECE, AVANT FIBER OPTIC HIGH SPEED HANDPIECE, MODEL #'S AVANT HS 100 & AVANT HS 200

Applicant: Ora Innovations, Inc.
Product code: EFB
Advisory panel: Dental
Date received: 1998-09-10
Decision date: 1998-11-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Portland, OR, 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.