K082716

Substantially Equivalent

A-DEC/W&H ALEGRA AIR-DRIVEN HIGHSPEED HANDPIECE, MODEL TE-97, TE-98, A-DEC/W&H ALEGRA HANDPIECE ATTACHMENT, MODEL HE-43

Applicant: A-Dec, Inc.
Product code: EFB
Advisory panel: Dental
Date received: 2008-09-17
Decision date: 2009-01-15
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Newberg, 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.