510(k) K974737— ASTRA TECH IMPLANT DENTAL SYSTEM

Substantially Equivalent

Astra Tech, Inc.

Clearance details

Applicant: Astra Tech, Inc.
Product code: Code DZE
Advisory panel: Dental
Date received: 1997-12-19
Decision date: 1998-03-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lexington, MA, US

Adverse events under product code DZE

product code DZE

Death: 28
Injury: 3,367,041
Malfunction: 19,958
Other: 13
Total: 3,387,040

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.