510(k) K885115— IMD 7GX

Substantially Equivalent

Medical Dental Technology Co.

Clearance details

Applicant: Medical Dental Technology Co.
Product code: Code EFB
Advisory panel: Dental
Date received: 1988-12-12
Decision date: 1989-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ventura, CA, 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.